Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training
What Is Pharmacovigilance? - Definition, Jobs, Salary, And Pharmacovigilance Certification
Pharmacovigilance
A Guide All About Pharmacovigilance
To increase your chances of getting hired or promoted, scroll below or enroll in our CCRPS Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM Course which covers drug safety and pharmacovigilance training
What is pharmacovigilance?
Pharmacovigilance Is The Study Of Two Primary Outcomes In The Pharmaceutical Industry:
Safety And Efficacy.
Essentially, it asks does a drug work and is it safe?
Pharmacovigilance is the process of monitoring the effects of drugs, both new and existing ones. This includes collecting data, analyzing it, and taking steps to prevent any negative effects. Pharmacovigilance must happen throughout the entire life cycle of a drug, from when it is first being developed to long after it has been released on the market.
What is the Aim Of Pharmacovigilance?
Pharmacovigilance is required through the entire life cycle of a drug – starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market.
Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.
It can be broken down into three main sub-specialisms:
Surveillance: Surveillance is geared towards risk management and signal detection. Roles in this specialism focus analysis of drug safety information gathered from other professionals. Surveillance is responsible for creating development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for drugs that are on the market.
Operations: Operations focus on collecting and recording information during preclinical development, early clinical trials, and gathering real-world evidence (RWE) of adverse events reported by medical professionals and patients. Operations may also create standard operating procedures (SOPs), individual case study reports, and regulatory reports.
Systems: Systems is concerned with the development of robust systems to store and manage data relating to pharmacovigilance. It involves keeping abreast of changing regulations and guidance in the pharmacovigilance industry and ensuring compliance at all levels of an organization.
The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that an organization's pharmacovigilance system meets all applicable requirements.
What is Pharmacovigilance Training?
If you’re looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, certification is crucial.
If you run a company and want to provide your staff with drug safety training to increase their knowledge and provide a safer working environment, our course is for you too.
We even help train Senior PVs from Fortune 500 companies to improve their efficiency and compliance.
No experience? No worries!
Our triple-accredited Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM is designed to teach you all you need to know in just 1 week!
Recognized Drug Safety Training I 180 Hours I On-Demand I Accredited I 25+ Modules I Training Compliance I Instant Enrolment I 1+Wk Certification I
What do Pharmacovigilance Officers do?
The exact nature of each role varies, but in essence, Pharmacovigilance Officers (PVs) collect adverse event data on drugs (Phase 4) to analyse and create usage warnings for the drug.
Some roles insist on physicians, nurses, or those with a Master of Science degree. A Master’s in pharmacovigilance is your best route into the industry – but that takes up to 2 years and is very expensive.
Your quicker route into the industry is with a drug safety accreditation.
Please note: A minimum of an associate degree is required to take any training course, including ours.
How To Get Into Pharmacovigilance
The CCRPS pharmacovigilance certification to provide advanced training for entry level pharmacovigilance to ensure you are fully prepared for a career in drug safety monitoring. We are a non-profit organization dedicated to providing advanced pharmacovigilance training to students at all stages of their careers.
The courses provide you with theory and practical-based learning in pharmacovigilance and give you vital industry experience.
Our pharmacovigilance training courses meet
WHO-ISoP and FDA guidelines and are accredited by the ACCRE and other recognized accreditation boards.
You’ll learn the basics of pharmacovigilance, why it’s necessary, its history, and how to find career opportunities within the industry.
You’ll look at different methodologies, pharmacovigilance regulation, pharmacovigilance audit and risk management, and vaccine pharmacovigilance.
You’ll also discover where to find further information to enhance your pharmacovigilance knowledge and study individual case reports to get to grips with the finer details of the subject.
At the end of the course, you will receive your certification. Then you’re ready to set out on your pharmacovigilance career.
After achieving your certification, you’ll open up a world of opportunities in pharmacovigilance and be qualified for entry-level roles including, but not limited to the following Drug Safety Jobs:
Pharmacovigilance Jobs
Pharmacovigilance Jobs Entry Level
18,000 Pharmacovigilance Jobs (always include a SPECIFIC cover letter for all jobs and follow up at least twice by email if you do not hear back to show interest to every single job).
Drug safety or Pharmacovigilance scientist (specialist or associate)
Drug safety or PV manager
Safety or PV reviewer
Pharmacovigilance Quality Compliance
Clinical Quality specialist
Medical Safety scientist/specialist/reviewer
Local safety officer
Clinical trial project safety associate (reviewer or specialist)
MedDRA coder
Pharmacovigilance safety and analytics reporting analyst/specialist/associate
Pharmacovigilance Auditor or PV Inspection readiness officer
• Safety or Pharmacovigilance Physician (medical director, MD/MBBS, IMG)
• Safety Compliance Writer
• Good PV Practices manager
• GCP specialist
• Pharmacovigilance vendor
• Case processing specialist
• Clinical trial case processing safety specialist
• Post-marketing case processing safety specialist
• Epidemiology safety associate (MPH) • Risk management manager
• Signal management specialist
• Periodic reporting specialist• Regulatory affairs safety specialist
You’ll also be qualified to act as an onsite safety representative for the duration of a given contract.
Pharmacovigilance Salary
The pandemic has demonstrated just how vital the pharmaceutical industry is to the smooth running of the country and the economy. And with the average entry-level salary in pharmacovigilance in the region of $69,000, it provides a unique opportunity to do your duty and be well-rewarded.
Once you are experienced in
pharmacovigilance, you can expect to command a salary of around $114,000.
And after 3-10 years in the industry, you can expect to earn $136,000. Based on salary, the US is the best country for pharmacovigilance jobs although pharmacovigilance is paid well globally as well.
We have trained over 1,800 clinical research and pharmacovigilance professionals and cover global clinical safety and pharmacovigilance as well as argus safety data base certification in our online, on-demand course. Our drug safety training is provided online and can be completed in less than a week. This is a great alternative to a diploma course in pharmacovigilance as you can finish quickly and still get an advanced level of understanding under your belt.
You can speak with our enrollment advisors for assistance in pricing and scholarship. Completed certification helps demonstrate your interest and knowledge to employers.
A career in pharmacovigilance is rewarding both personally and financially.
But like all new career paths, it can be difficult to gain experience or demonstrate your commitment from the outside. Achieving an accredited PV certification shows potential employers that you are serious about a career in the industry. It proves that you have the required knowledge and understanding of pharmacovigilance to add value to their organization.
For further details, call and speak to one of our 24/7 enrollment representatives through the orange chat box.
Good pharmacovigilance practice - ICH GCP guidelines for pharmacovigilance
Pharmacovigilance certification
Pharmacovigilance Certification
by CCRPS pharmacovigilance training institute is a globally-accepted, accredited Online Pharmacovigilance Training Course
Fundamentals Of Global Pharmacovigilance
Introduction to Drug Safety and PV FREE PREVIEW
Key PV Terminology (Side Effect, Drug Safety, and Risk Terms) FREE PREVIEW
International Regulatory Requirements and Guidelines Overview FREE PREVIEW
Pharmacovigilance Quiz
Regional Regulatory Requirements (FDA, EMA, Japan, China) FREE PREVIEW
Postmarketing Surveillance (PMS) and Safety Management FREE PREVIEW
GVP - Pharmacovigilance Abbreviations Advanced Review of Adverse Event Reporting
Advanced Review Of Pharmacovigilance
Advanced Practice of Pharmacovigilance Pharmacovigilance Quiz
Additional Encompassing and Confusing Terms in Pharmacovigilance
MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
Pharmacovigilance Quiz
Need for Pharmacovigilance
The History of Pharmacovigilance FREE PREVIEW Roles in Pharmacovigilance Pharmacovigilance Quiz
Key Stakeholders in Pharmacovigilance Pharmacovigilance Quiz
Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)
Pharmacovigilance Quiz
Signal Detection (Detection, Validation, Prioritization, and Action)
Pharmacovigilance Quiz
Risk Assessment, Plan, and Management Pharmacovigilance Quiz
Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)
Post-authorization/Post-marketing Regulations in Pharmacovigilance
Argus Safety Database Certification
Argus Safety Database Certification Part 1 (Into and Video Demos)
Argus Safety Database Certification Part 2 Argus Safety Database Certification Part 3 Argus Safety Database Certification Part 4 Argus Safety Database Certification Part 5 Argus Safety Database Certification Part 6 Oracle Argus Safety User Guide
Resources
International Pharmacovigilance Initiatives and Guidelines - EMA
DIA Safety and Pharmacovigilance Competencies
Pharmacovigilance Career Resources
WHO-ISoP Pharmacovigilance Resources
E2E-Pharmacovigilance Planning
GVP XVI Addendum: Educational Materials
GVP Module I-IV PV Systems, PSMF, Inspections & Audits
GVP I: Pharmacovigilance Systems
GVP VIII: Post-authorisation Safety Studies
GVP III: Pharmacovigilance Inspections
GVP IX Addendum: Methodological aspects
GVP V: Risk management systems
GVP IX: Signal management-
GVP VIII Addendum: Requirements- recommendations_en-1
GVP XV: Safety Communication
GVP XVI: Risk-minimization measures
GVP II: Pharmacovigilance System Master File
GVP VI: Duplicate Management
GVI VI: Pharmacovigilance Audits
GVP X: Additional Monitoring
GVP VII: Periodic Safety Update Report
GVP VI: Collection, management, and submission of reports
Pharmacovigilance Definition
Investigational product (IP): Any drug, device, therapy, or intervention after Phase I trial
Event: Any undesirable outcome (i.e. undesired laboratory finding, symptom, or disease)
Adverse event/experience (AE): Any related OR unrelated event occurring during use of IP
Adverse drug reaction/effect (ADR/ADE): AE that is related to product
Serious Adverse Event (SAE): AE that causes death, disability, incapacity, is life- threatening, requires/prolongs hospitalization, or leads to birth defect
Unexpected Adverse Event (UAE): AE that is not previously listed on product information
Unexpected Adverse Reaction: ADR that is not previously listed on product information
Suspected Unexpected Serious Adverse Reaction (SUSAR): Serious + Unexpected + ADR
Causality assessment: Review of drug (i.e. pharmacology, pathophysiology, time overlap of event and IP administration, dechallenge and rechallenge, confounding patient-specific disease manifestations or other medications, and other explanations) to determine if certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable.
Dechallenge vs. Rechallenge: Causality assessed by measuring AE outcomes when withdrawing vs. re-administering IP
Causal relationship: Determined to be certain, probable/likely, or possible (AE + Causal -> ADR)
Seriousness: based on outcome + guide to reporting obligations (i.e. death SAE -> report in 3 days) mnemonic: seriOOusness = OutcOme
• Severity: based on intensity (mild, moderate, severe) regardless of medical outcome (i.e. severe headache -> not serious) mnemonic: severiTTy = InTensiTy
• Temporal relationship: Positive if AE timing within use or half-life of drug (positive, suggestive, compatible, weak, negative)
• Signal: Event information after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying (PMS = signal detection, validation, confirmation, analysis, & assessment and recommendation for action)
• Identified risk: Event noticed in signal evaluation known to be related/listed on product information
• Potential risk: Event noticed in signal evaluation scientifically related to product but not listed on product information
• Important risk/Safety concern: Identified or potential risk that can impact risk-benefit ratio
• Risk-benefit ratio: Ratio of IP’s positive therapeutic effect to risks of safety/efficacy
• Summary of product characteristics (SmPC/SPC): guide for doctors to use IP
Good Pharmacovigilance Practice - ICH GCP guidelines for pharmacovigilance
E2A: Clinical safety data management: Definitions and standards for expedited reporting
What is e2b in pharmacovigilance? E2B: Electronic reporting of adverse events: Implements electronic reporting R3 E-ICSR Implementation Guide I Link CIOMS I to E2B Guide
E2C: Periodic benefit- risk evaluation report (PBRER): Format and content of safety updates for reporting at intervals to regulatory authorities
E2D: Post-approval safety data management: Definitions and standards for expedited reporting: Guidance for gathering and reporting information
E2E: Pharmacovigilance planning: Helps to make PMS plan, especially in early Phase IV
E2F: Development Safety Update Report (DSUR): Standard for periodic reporting on drugs
M1: Medical dictionary for Regulatory activities (MedDRA)
M4: The Common Technical Document (CTD): Formatting of reports to regulatory bodies (M4 Organization, M4Quality, M4Safety, M4Efficacy)
CIOMS I: The international reporting form (links with ICH E2B)
CIOMS II: Periodic safety update reports manual
CIOMS III: Core data sheets
CIOMS IV: Benefit-risk assessments
CIOMS VI: Clinical trial safety data
CIOMS VII: Development safety update reports
CIOMS VIII: Practical Aspects of Signal Detection in Pharmacovigilance
Global Pharmacovigilance laws and regulations - IAOCR Directory
Local Pharmacovigilance Regulatory Bodies
Australia – Therapeutic Goods Administration (TGA)
New Zealand – MEDSAFE
North America
Canada – Health Canada ~2%
USA* – FDA: Food and Drug Administration ~33%
Central/South America
Argentina – ANMAT
Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)
Chile – Instituto de Salud Publico (ISP)
Columbia – Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
Costa Rica – Ministerio de Salud
Cuba – CECMED
Dominican Republic – Dirección General de Drogas y Farmacias
Jamaica – Ministry of Health
Mexico – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Paraguay – Ministro de Salud Pública y Bienestar Social
Peru – Ministerio de Salud
Uruguay – Ministerio de Salud Publica
European Union* – EMA: European Medicines Agency ~17%
Armenia – Scientific Centre of Drug and Medical Technology Expertise
Austria – Agency for Health and Food Safety (AGES)
Belgium – Federal Agency for Medicines and Health Products
Bulgaria – Bulgarian Drug Agency
Croatia – Agency for Medicinal Products and Medical Devices of Croatia
Cyprus – Ministry of Health
Czech Republic – State Institute for Drug Control
Denmark – Danish Medicines Agency
Estonia – State Agency of Medicines
Finland – Finish Medicines Agency
France – Agence Nationale de Sécurité du Medicament et des Produits de Santé
Germany – Federal Institute for Drugs and Medical Devices
Georgia – Regulation Agency for Medical and Pharmaceutical Activities
Greece – National Organisation for Medicines
Hungary – National Institute of Pharmacy
Iceland – Icelandic Medicines Agency
Ireland – Irish Medicines Board
Italy – National Institute of Health
Lithuania – State Medicines Control Agency
Luxembourg – Ministry of Health
Malta – Maltese Medicines Authority
Moldova – Medicines Agency
Netherlands – Medicines Evaluation Board
Norway – Norwegian Medicines Agency
Poland – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal – National Authority of Medicines and Health Products
Romania – National Medicines Agency
Russia – Ministry of Health of the Russian Federation• Serbia – Medicines and Medical Devices Agency of Serbia
• Slovakia – State Institute for Drug Control • Slovenia – Ministry of Health
• Spain – Spanish Medicines Agency
• Sweden – Medical Products Agency• Switzerland – Swiss Agency for Therapeutic Products
• Ukraine – Ministry of Health
• United Kingdom – Medicines and Healthcare Regulatory Agency (MHRA)
• Bahrain – I-SEHA
• Egypt – Ministry of Health
• Iran – Ministry of Health
• Israel – Ministry of Health
• Jordan – Jordan Food and Drug Administration
• Lebanon – Ministry of Public Health
• Saudi Arabia – Saudi Food and Drug Authority
• United Arab Emirates – Ministry of Health
• Bangladesh – Directorate General of Drug Administration (DGDA)
• Bhutan – Drug Regulatory Authority
• China* – CFDA/NMPA: State Food and Drug Administration
• India – Central Drug Standards Control Organization (CDSCO)
• Indonesia – POM (Pengawas Obat dan Makanan)
• JAPAN* – PMDA: Ministry of Health, Labour and Welfare ~12%
• Korea (South) – Korean Food and Drug Administration (KFDA) ~1%
• Laos – Food and Drug Department
• Malaysia – Ministry of Health (MOH)
• Nepal – Department of Drug Administration
• Philippines – Department of Health (DOH)
• Singapore – Health Sciences Authority (HSA)
• Sri Lanka – Ministry of Health (MOH)
• Taiwan (Republic of China) – Taiwan Food and Drug Administration (TFDA)
• Thailand – Food and Drug Administration of Thailand
• Vietnam – Drug Administration of Vietnam
• Algeria – Ministry of Health and Population • Botswana – Ministry of Health (MOH)
• Burkina Faso – Le Ministère de la Santé• Ghana – Food and Drugs Authority
• Kenya – Pharmacy and Poisons Board
• Morocco – Ministry of Health
• Nigeria – National Agency for Food and Drug Administration and Control
• Rwanda – Ministry of Health
• Senegal – Ministère de la Santé et de l’Action Sociale
• South Africa – Medicines Control Council (MCC)
• Swaziland – Ministry of Health
• Tanzania – Tanzania Food and Drug Authority (TFDA)
• Uganda – National Drug Authority
Good Pharmacovigilance Practice
Good Pharmacovigilance Practice Modules: A Comprehensive Guide to EMA GVP Modules
In 2024, guaranteeing the secure and compelling utilize of medications remains vital, and following to great pharmacovigilance hones is significant. The European Medications Organization (EMA) has set up comprehensive rules to guarantee the secure observing of drugs all through their lifecycle. Our pharmacovigilance preparing program offers certification in these modules, recognized by IAOCR and right now attempted by over 6,000 students.
Compliant with universal guidelines, great pharmacovigilance hones require that companies or showcasing authorization holders (MAHs) actualize strong frameworks to screen pharmaceutical security, assemble information on potential dangers, and instantly report any suspected unfavorable responses. Fast distinguishing proof of security issues and suitable activity by MAHs are imperative.
Moreover, EMA's Hazard Administration Plans give extra direction on overseeing item dangers all through their lifecycle. These plans address chance minimization methodologies, benefit-risk appraisals, extra observing frameworks, and post-marketing studies.
It is basic for pharmaceutical companies to follow to great pharmacovigilance hones to guarantee quiet security and the opportune conveyance of quality solutions without undue dangers or delays. Taking after these rules makes a difference defend open wellbeing by empowering quick discovery of security signals some time recently genuine hurt happens.
1.Pharmacovigilance Systems
The Guideline on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems outlines key principles, requirements and expectations for managing effective pharmacovigilance systems, as well as providing guidance on how to develop and maintain a quality system. The document provides a comprehensive overview of the regulatory framework and highlights the importance of an efficient, effective and compliant pharmacovigilance system. It includes information such as the definition of what constitutes a PV system, the role of relevant parties in setting up and operating such a system, expectations regarding PV processes and procedures, criteria for evaluating adequacy of PV systems, risk management activities, safety data exchange agreements and safety reporting procedures.
The document outlines the responsibilities associated with setting up a PV system and maintaining its quality assurance program. This includes ensuring that applicable laws or regulations are followed; obtaining the necessary resources (people, equipment); identifying appropriate roles for personnel involved in PV activities; developing policies, procedures and standards; monitoring performance; making sure that any changes to the system are properly validated/re-validated; implementing risk management plans; establishing an internal audit program; performing regular internal audits to ensure compliance with applicable laws or regulations; interacting with external organizations involved in safety surveillance activities. Additionally, it discusses topics such as data protection requirements, individual case safety report reconciliation processes, periodic safety update reports (PSURs), risk management plans (RMPs), signal detection methods and other related topics.
Overall this guideline is an essential reference tool for industry professionals responsible for setting up or maintaining pharmacovigilance systems. It provides a detailed description of all aspects relating to pharmacovigilance systems including those related to regulatory requirements, quality assurance programs and data protection measures. This makes it an ideal source of information for industry professionals looking to stay informed about best practices in this field.
2. Pharmacovigilance System Master File
The Guideline on Good Pharmacovigilance Practices (GVP) Module II – Pharmacovigilance System Master File (Rev 2) is a comprehensive document that outlines the best practices for companies involved in the pharmaceutical industry to ensure the safe use of their products. The document covers topics such as the required contents of a pharmacovigilance system master file (PSMF), recommendations for setting up, running and maintaining a PSMF, as well as safety-related responsibilities for healthcare professionals and companies.
The GVP Module II provides clear guidance on what should be included in the PSMF, including elements such as organizational information, operational processes, safety data management and reporting, safety risk management and analysis, and communication processes. It also outlines good practices related to quality assurance such as validation of data entry systems and implementation of change control procedures. Moreover, it provides detailed instructions related to specific roles within a pharmacovigilance system such as medical advisors, clinical evaluation experts and signal detection staff.
In addition to providing recommendations on how to implement adequate pharmacovigilance systems, this guideline also includes discussion points on how companies can validate their own individual systems. This includes guidance on how to audit against established standards such as those outlined by the European Medicines Agency (EMA). Furthermore, it outlines requirements for drug development plans including preclinical studies, clinical trials, post-authorization studies and post-marketing surveillance programs.
Overall, this document is an invaluable resource for anyone involved in any aspect of drug safety or pharmacovigilance. It provides clear guidance about what constitutes an adequate pharmacovigilance system for both healthcare professionals and companies involved in the pharmaceutical industry. Its detailed descriptions make it easy to understand exactly what needs to be done from concept through implementation and operation of a PSMF. Additionally its discussion points provide valuable insights into how existing systems may be evaluated or improved upon if needed.
3. Pharmacovigilance Inspections
The Guideline on Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections (Rev 1) provides an overview of the inspection process and methodology used in pharmacovigilance. This document is intended to standardize the approach taken by authorities when carrying out inspections as part of their pharmacovigilance activities. The document starts by providing an overview of the objectives and scope of inspections, as well as a list of key elements that should be assessed during such inspections. It then goes on to outline the organization and conduct of inspections, including the roles and responsibilities of all those involved, before concluding with a discussion of post-inspection activities.
The document contains information on how to prepare for an inspection, including identifying risks, developing a detailed plan and appointing appropriately qualified inspectors. It also covers topics such as evidence gathering, reporting requirements, defining corrective and preventive actions (CAPA), handling disagreements between authorities and documentation requirements. The document also includes guidance on how to manage conflicts of interest during inspections, assess data integrity issues in clinical studies or establish a dialogue between authorities and inspected companies.
Overall, this guideline provides comprehensive information about conducting pharmacovigilance inspections. It sets out detailed instructions for all stages of such inspections – from preparing for them to taking corrective actions afterwards – helping ensure that these activities are carried out in a consistent manner across different countries. As such, this guideline is likely to be beneficial for both authorities responsible for managing safety concerns related to medicines and inspected companies which must comply with relevant regulations.
4. Pharmacovigilance Audits
The Guideline on Good Pharmacovigilance Practices (GVP) Module IV provides guidance for conducting pharmacovigilance audits. This document is intended to provide an overview of the essential elements of a robust quality system and auditor qualification, planning and preparation for the audit, conduct of the audit, closure and follow-up activities, and reporting.
The main objectives of conducting pharmacovigilance auditing are to ensure that the pharmacovigilance system meets applicable regulatory requirements and industry standards, while also promoting continuous improvement in safety management. The document outlines the expectations for planning and preparing for an audit including scope, criteria, documents to be reviewed, personnel to be interviewed and potential sources of evidence. It addresses important considerations such as effective communication with stakeholders during planning and performance of the audit.
The document also covers criteria to be used when selecting auditors to ensure objective assessments. Qualifications should include relevant knowledge within the area of pharmacovigilance as well as experience in conducting audits. Additionally, it specifies standards for verbal/written communications with all parties involved during an audit including respect for confidentiality/privacy requirements.
The document describes principles related to conducting the audit including appropriate documentation methods such as notes from witness interviews or observation forms. Guidelines are provided regarding evidence gathering techniques such as sample size determination, selection of subjects or records to review, duration of observations and additional topics related to ensuring effective data collection techniques are employed when necessary.
Additionally, this guideline outlines requirements for properly closing an audit including findings discussions with all parties involved followed by appropriate action plans that address any non-conformities found during the process. This action plan should aim at remediation of deficiencies found during either corrective or preventative actions if necessary/justified as well as a timeline for completion/follow-up actions on actions taken. Lastly, it describes expectations related to reporting post-audit activities which should include written reports addressing nonconformities found along with recommendations on corrective actions taken or additional preventive measures needed in order to ensure compliance with GVP guidelines going forward.
5. Risk Management Systems
The Guideline on Good Pharmacovigilance Practices (GVP) Module V- Risk Management Systems, revised for 2020, is a comprehensive document provided by the European Medicines Agency that outlines a framework for risk management systems of pharmaceutical products. It provides detailed guidance for manufacturers and marketing authorization holders during their production and distribution of medicinal products in Europe. The guideline covers topics such as the safety assessment process, risk minimization activities, communication of safety information to healthcare professionals and patients, pharmacovigilance audit procedures and training requirements.
The main aim of GVP Module V is to ensure that the risks associated with medicinal products are managed effectively throughout their lifecycle. This is achieved through an effective risk management system (RMS). To this end, the GVP sets out five core principles that should be adhered to when designing and implementing an RMS: monitoring and evaluation of safety information; risk minimization strategies; communication of safety information; audit and inspection; and training requirements.
Each principle is then broken down into more detailed elements which manufacturers/marketing authorization holders should consider when designing their RMS. These include: establishing objectives for the RMS; setting up a robust infrastructure to monitor safety data; developing risk minimization plans; communicating safety information to stakeholders on a regular basis; conducting audits/inspections on a regular basis; ensuring staff are trained appropriately in pharmacovigilance practices; setting up reporting systems to enable timely alerts if any significant new risks are identified; assessing performance metrics regularly to ensure processes remain effective over time.
6. Individual Case Safety Reports
The Guideline on good pharmacovigilance practices (GVP) Module VI provides guidance for companies and organizations in the collection and management of individual case safety reports (ICSRs) as well as their submission to regulatory authorities. The main purpose of this module is to ensure that pharmacovigilance activities are performed in a consistent and effective manner across the EU Member States, in order to protect public health, improve patient safety, and strengthen confidence in healthcare products.
The module covers topics such as process for ICSR collection, management, and submission process; risk management plan; responsibilities; quality control measures; data integrity requirements; monitoring of adverse events reporting systems; ICSR privacy considerations; electronic exchange of ICSRs between marketing authorization holders and national competent authorities; and post-marketing surveillance.
In addition to providing practical guidance on these topics, the module also outlines best practices for maintaining a comprehensive pharmacovigilance system. These include establishing an appropriate risk management plan for each authorized medicinal product, assigning roles and responsibilities appropriately, collecting timely ICSRs from all relevant sources (including spontaneous reports from healthcare professionals or patients), tracking safety signals on an ongoing basis, ensuring data integrity when exchanging ICSRs electronically with regulatory authorities, ensuring the security of personal data related to patients who report adverse reactions, and performing regular monitoring activities to assess compliance with pharmacovigilance obligations.
Overall, the Guideline on good pharmacovigilance practices (GVP) Module VI is a valuable resource for companies and organizations that seek to ensure that their pharmacovigilance operations are up-to-date with current regulations and standards. It provides useful information on how to develop an effective ICSR collection, management, and submission process while also emphasizing best practices for maintaining a comprehensive pharmacovigilance system that is compliant with applicable laws.
7. Period Safety Update Reports
The Guideline on good pharmacovigilance practices (GVP) Module VII is designed to provide guidance for the development and submission of periodic safety update reports (PSURs). This document provides information on the regulatory aspects, content and format for PSURs, as well as best practices for preparing and submitting them in accordance with the applicable risk management plan.
The GVP Module VII outlines the process needed to assess drug safety data from various sources, including spontaneous reports, clinical trials, epidemiological studies and post-authorization safety studies. It emphasizes that periodic safety reviews should be conducted at least annually and whenever new data suggests it is necessary. The main objective of a PSUR is to provide an assessment of the benefit-risk balance of a medicinal product over a defined period of time.
In order to ensure that all relevant data is accurately captured and tracked, the GVP Module VII recommends that companies maintain a comprehensive database containing both adverse event and non-adverse event information related to their products. This information should include any relevant clinical trial results or other relevant safety issues identified during pharmacovigilance activities. Additionally, the document outlines methods for evaluating reported events in order to identify potential safety signals.
Overall, Guideline on good pharmacovigilance practices (GVP) Module VII provides detailed guidance regarding the development and submission of periodic safety update reports (PSURs). It outlines processes for capturing, tracking, evaluating and assessing drug safety data from various sources. Furthermore, it discusses strategies for analyzing this data in order to identify potential safety signals which help inform regulatory decision making about a particular pharmaceutical product's risk-benefit balance over time.
8. Post Authorization Safety Studies
The Guideline on Good Pharmacovigilance Practices (GVP) Module VIII provides detailed guidance on the post-authorisation safety studies (PASS). This document is designed to help drug manufacturing companies, regulatory agencies and other stakeholders understand their respective roles and responsibilities in designing and conducting PASS.
The document outlines the principles of good pharmacovigilance practice and incorporates several international standards including those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The document also highlights the potential benefit of using available data sources such as Electronic Health Records and administrative healthcare databases, as well as patient registries.
In addition to general requirements related to PASS design, GVP Module VIII outlines specific requirements regarding patient eligibility criteria, study protocol adherence, sample size calculation and analysis, ethics/informed consent requirements, as well as specific reporting requirements.
The document contains clear instructions on how sponsors should prepare a detailed risk management plan (RMP) with respect to PASS. This includes outlining different types of safety monitoring procedures that should be conducted during a study. Furthermore, it provides guidance on providing adequate training to ensure appropriate execution of the RMP. Moreover, it outlines the importance of appropriately packaging and labelling test articles used in clinical trials to minimize any potential risks or harm associated with them.
Overall, GVP Module VIII provides comprehensive guidance for all stakeholders involved in Post-Authorisation Safety Studies by outlining clear roles and responsibilities as well assessing potential risks associated with these studies. It serves as an essential reference guide for manufacturers who wish to design effective PASS protocols that adhere to international standards in order to ensure patient safety while at the same time promoting innovation within the industry.
9. Signal Management
The Guideline on Good Pharmacovigilance Practices (GVP) Module IX on Signal Management is a comprehensive set of guidelines which provides the framework for the appropriate management of signals and safety issues related to medicines. It outlines the process for detecting and evaluating potential safety issues and risks associated with medicinal products, as well as providing guidance on when additional investigations should be considered, and how to respond when safety signals are identified. The document focusses on areas such as risk minimisation plans, benefit-risk assessments, laboratory tests, product recalls and market withdrawals.
The GVP Module IX begins by outlining the definitions and concepts associated with signal management. These include definitions of what a signal is, how a signal should be classified, when it is appropriate to consider further action and how to differentiate between pharmacovigilance activities and regulatory actions. This section also provides guidance on data sources which can be used to identify signals, including both spontaneous reports from healthcare professionals or consumers as well as epidemiological studies.
The next section details specific aspects of signal management such as risk minimisation activities, benefit-risk assessments, laboratory investigations and product recalls or market withdrawals. It outlines key points such as: planning risk minimisation strategies in advance; monitoring effectiveness; assessing the benefit-risk balance at regular intervals; conducting laboratory tests which are relevant to safety issues; recalling or withdrawing products where necessary; ensuring availability of up-to-date information about risks associated with medicines; considering other types of regulatory action where appropriate; maintaining records of all decisions made related to signal management; and reporting/publishing new information regarding any changes in risk assessment/benefit-risk balance.
Finally, GVP Module IX provides detailed guidance on post-marketing surveillance activities which should be conducted following implementation of any risk minimisation plans. This includes setting up systems for monitoring changes in safety profile after introduction into use in humans or in the environment, implementing quality control processes for data capture & analysis, garnering collaboration from stakeholders (e.g healthcare professionals & customer feedback), sharing data with other organisations/authorities where appropriate ,and implementing communication plans so that stakeholders are kept informed of any changes in risk assessment/benefit-risk balance due to new evidence becoming available over time.
10. Additional Drug Safety Monitoring
The Guideline on Good Pharmacovigilance Practices (GVP) Module on Additional Monitoring offers a comprehensive guide to the principles, methods and processes of additional monitoring in the field of pharmacovigilance. This document outlines the purpose, rationale and requirements of additional monitoring activities as well as providing practical guidance for its implementation. The module is divided into five sections: Introduction; Overview; Objectives; Policies and Procedures; and Resources and Tools. In addition, it provides detailed best practice recommendations for each of these subject areas.
The Introduction section offers an overview of pharmacovigilance as well as outlining the structure and purpose of GVP Module X on Additional Monitoring. It also provides definitions for key terms related to this area such as safety surveillance, signal detection, signal assessment, signal evaluation, risk management plan (RMP), post-marketing commitment (PMC) etc.
The Overview section provides a general overview of additional monitoring including an explanation of its objectives, purpose and importance in the management of drug safety risks. It goes on to discuss how additional monitoring data can be used by authorities to make informed decisions regarding marketing authorization or changes to an authorized product's RMP. The section also looks at how regulators can assess the adequacy of existing safety information and consider whether further data collection should be undertaken through additional monitoring activities.
The Objectives section outlines in detail the objectives to be fulfilled when undertaking additional monitoring activities such as obtaining further safety information about a marketed product or conducting ongoing risk-benefit assessments necessary for regulatory decision making about medicine availability or changes to an authorized product's RMP. It also discusses how appropriate target populations can be identified in order maximize benefit from the activity while minimizing risk from potential harms caused by inappropriate use or misuse of medicines.
The Policies and Procedures section explains in detail what should be included when developing procedures for implementing additional monitoring activities such as setting objectives for data collection, deciding target populations for data collection, identifying relevant sources of information (including electronic health records) etc. It also covers legal considerations such as patient consent requirements when collecting personal data through registries or other sources outside hospital settings etc., which are important when planning any form of clinical trial activity that uses anonymized patient data collected retrospectively from various sources (e.g., primary care centers).
Finally, the Resources and Tools section suggests some practical tools that may help with developing appropriate procedures when implementing additional monitoring activities such as questionnaires that could be used to collect patient reported outcome measures (PROMs) etc. In addition it outlines relevant international frameworks/agreements which must be taken into account when collecting global safety data sets through international registry networks such as those developed through ICH-GCP partnerships between different countries/regions across Europe or North America etc..
Overall this Guideline on Good Pharmacovigilance Practices Module X Additional Monitoring is an essential resource for anyone involved with designing or implementing pharmacovigiance systems since it provides comprehensive best practice advice that will help ensure safe use/distribution/monitoring of medicines worldwide
15. Pharmacovigilance Safety Communication
The Guideline on good pharmacovigilance practices (GVP) Module XV Safety Communication was developed to provide guidance to pharmaceutical companies and other healthcare stakeholders involved in the management of medicinal products. This document contains detailed instructions on how to effectively communicate risk related information about medicinal products.
The guidelines are designed to ensure that such communication is consistent, timely and accurate. It also highlights the importance of making sure that both healthcare professionals and patients have access to sufficient information so that they can make informed decisions about the medicine they are taking.
The document outlines a number of principles for effective safety communication, including: ensuring that all risk related information is identified and included in the communication; providing clear, accurate, up-to-date information; understanding who needs to be informed; responding quickly to questions raised by healthcare professionals; and making sure that patients have access to appropriate support after receiving information.
The guideline also sets out various requirements for monitoring and assessing the effectiveness of safety communications, including evaluating the impact of risk minimisation measures, collecting feedback from health professionals and consumers following safety communications, conducting surveys among healthcare professionals and monitoring changes in prescribing behaviour. The documentation also provides advice on dealing with adverse events associated with medicines as well as what steps should be taken when product recalls or withdrawals occur.
Overall, this Guideline on good pharmacovigilance practices (GVP) Module XV Safety Communication provides a comprehensive overview of best practices relating to safety communications concerning medicinal products. It provides specific advice on how pharmaceutical companies should communicate risk-related information about their medicines, as well as how to monitor the effectiveness of such communication. The guidance is invaluable for all stakeholders involved in managing medicinal products so that they can ensure patient safety is maintained at all times.
Want to understand good pharmacovigilance practice modules through examples, video lectures, and quizzes all while receiving The IAOCR internationally recognized certificate available for PV officers? Consider enrolling in CCRPS Pharmacovigilance certification.
Introduction to Pharmacovigilance
Fig 1: Drug safety and pharmacovigilance
Introduction to pharmacovigilance
According to the world health organization, "pharmacovigilance also know as drug safety, is the pharmacological science related to the collection, detection, assessment, monitoring, and prevention of adverse effects of the pharmaceutical drugs"
Aims of pharmacy vigilance are the following
Fig 2: why do we need pharmacovigilance
• Improve patient care about the drugs and keep the patient safe from adverse effects of drug
• Pharmacovigilance keep track of any drastic effect of the drug
• To research the efficacy of the drug and check effects of drugs during trials to the pharmacy and then keep monitoring their effects for many years
• Bring improvement in the public healthcare system by a thorough assessment of drugs effect on the body
• Promote training and knowledge about this field of medicine
• To know the mechanisms of the drug inside the human body
• To encourage safe and rational use of medicines
Fig 4: Phases of drug development
Objectives of pharmacovigilance
• To properly detect the unknown adverse effect and drug interaction
• Distribution of information about the adverse effect of drugs and drug interactions so that they occur less frequently
• Timely correction of therapeutic errors
• Reevaluation of the risk-benefit balance of medicine, so we can effectively use those drugs for a patient having more benefits and fewer side effects
• Identifications of mechanisms that cause adverse effects of drugs
Fig 3: Stakeholders in pharmacovigilance
There are mainly four stake holders in pharmacovigilance
1- Patient
2- Doctor or pharmacist
3- Marketing authorization holder
4- Regulators such as authorities, committee
Steps of pharmacovigilance
Fig 5: PV workflow
Step 1 is the collection of reports about the adverse effect and all adverse reactions of the drugs. All adverse reactions, including serious and unexpected effects, are subjected to expedited reporting.
Step 2 involves receiving the cumulative reports regarding the safety of drugs and sending those reports to all the regulatory authorities.
Step 3 The process of determining the specific adverse effect associated with a specified drug and then comparing this drug with another drug having a similar worse effect.
Step 4 Management of adverse effects of the drugs. Receive information regarding the harmful effects on patients or population and seek a method to minimize these effects.
Pharmacovigilance regulations:
International Conference of Harmonization consists of authorities from India, Europe, and Japan with representatives of the correlating industries, health organization, and WHO as an observer. This conference provides guidelines regarding pharmacovigilance and good drugs. There is stepwise development of instructions. At step four, there is a consensus internationally, and at step 5, an agreement for regulators to introduce the guidelines to legislation.
The principal role of pharmacovigilance is to ensure the safer usage of drugs. But the pressure is increasing on this field to analyze data about the adverse effect, monitor risk more broadly, and accurately reports patient events.
What information should we report to higher authorities?
• Any information on adverse drug reaction
• lack of efficacy of the drug
• Even when there is no observed adverse effect, report abuse of the drug, effect of overdose, and about drug administration during pregnancy
Free resources for introduction to pharmacovigilance:
https://pharmacovigilancetutorials.wordpress.com/2020/04/11/introduction-to-pharmacovigilance/
https://pharmacovigilancetutorials.wordpress.com/for-experienced/
https://pharmacovigilancetutorials.wordpress.com/
https://pharmacovigilancetutorials.wordpress.com/2020/04/11/pharmacovigilance-regulations/
https://pharmacovigilancetutorials.wordpress.com/2020/04/20/sources-of-adr-collections-and-reporting-forms/
https://pharmacovigilancetutorials.wordpress.com/2020/04/26/icsr-processing-tools/
https://pharmacovigilancetutorials.wordpress.com/2020/04/26/signal-detection-and-management/
Importance of a Drug Safety Pharmacovigilance Certificate Program
Drug Safety Pharmacovigilance Certificate Program
Fig1.1 Importance of drug safety and pharmacovigilance
Adverse drug reactions are common, often preventable, and are the cause of mortality and morbidity. Pharmacovigilance involves detection, assessment, and management of adverse effects of drugs. Education of health care professionals involved in drug prescription and administration is necessary to control and prevent adverse effects of drugs. To do this, we must focus on three pivotal aspects. (Raquel et al.,2018)
•Awareness
•Knowledge
•Reporting
Global drug safety and pharmacovigilance
As the worldwide movement for the safety of patients from the adverse effects of drugs has now become more prominent. Drug-related diseases cause a burden on healthcare around the world. A commonly quoted meta-analysis performed in the USA suggests that drug-related disease is causing the f death in many the individual. So many training and pharmacovigilance certificate programs are recognized worldwide regarding drug safety and pharmacovigilance.
The role of pharmacovigilance divides into three parts
• Identify drug drug-related
• To contribute to reducing these problems
• To increase knowledge about these problems
Table 1.1 outline of general pharmacovigilance training program
Pharmacovigilance training is an important way to prevent drug-related adverse effects. Pharmacovigilance is new and a small field. It is not a very well-established academic program. The current training programs of pharmacy, clinical medicine, and clinical pharmacology don’t provide enough training, which is necessary for pharmacy vigilance. Only a few universities offer special training in pharmacovigilance, the main reason for this is that it includes a wide range of subjects. The International Society of Pharmacovigilance (ISP) provides special training programs in pharmacovigilance.
Table 1.2 General topic for training of all pharmacovigilance employee
Two types of training occur in pharmacovigilance
1 – Training of pharmacovigilance staff those who will work on computer systems
2- Training of other company employees
The topic of the training should have been tailored to meet the requirement of jobs. There would of course be specific training that would train specifically all pharmacovigilance employee
New employees in the company first to receive appropriate training. The best way to get training is by face to face but this is not possible many times because of geographical difference. To overcome all these difficulties, various modalities are used in training such as self-training, face-to-face training, video conferencing, phone, and web-based classrooms. Nowadays, advanced pharmacovigilance training programs are now available because of the importance of this field in the healthcare profession.
Table 1.3: Topics specific to pharmacovigilance training program
Having a well-trained staff is very important for any pharmaceutical company. Effective and efficient management of training need can be carried out by carefully planning and identifying the employee need and matching them to company objectives. Many pharmacological institutes hold pharmacovigilance seminars to highlight the importance of drug safety and pharmacovigilance training.( Dr Vivek Ahuja and Dr Varun Sharma ., 2010)
Explore These Courses for Enhanced Learning:
Training of pharmacovigilance staff who will work on computer systems. To deepen your knowledge, check out the Pharmacovigilance Certification.
The topic of the training should cater to job requirements, providing detailed education for pharmacovigilance employees. Consider the comprehensive Pharmacovigilance Certification.
For new employees, overcoming geographical differences in training is crucial. Online courses like the Advanced Clinical Research Project Manager Certification and the Medical Monitor Certification are excellent resources.
Interested in coordinating clinical research? The Clinical Research Coordinator course provides essential training.
Explore the role of a Clinical Research Associate with the CRA course.
For those involved in international health care compliance, the ICH-GCP course offers critical guidelines and practices.
Assist in clinical trials more effectively by undertaking the Clinical Trials Assistant Training.
Physicians aiming to become principal investigators can benefit from the Advanced Principal Investigator Physician Certification.
Clinical Research Pharmacist: Alternative careers for pharmacists
Working in Drug Safety and Pharmacovigilance as a Pharmacist
Fig 1.1:Drug safety and pharmacy vigilance
Pharmacovigilance: Ensuring Drug Safety
Pharmacovigilance (PV) is a crucial field within pharmacy concerned with the lifelong monitoring of a drug's safety profile. It encompasses activities like:
Collection and detection of adverse effects (side effects or unintended consequences) experienced by patients using medications.
Assessment and evaluation of these adverse effects to determine their severity, frequency, and potential risk factors.
Developing strategies to minimize risks and improve the safety of medications.
Drug Safety Officers: Guardians of Public Health
Drug safety officers are the backbone of pharmacovigilance. They are responsible for:
Monitoring reports of adverse effects from various sources like healthcare professionals, patients, and clinical trials.
Analyzing data to identify potential safety concerns or trends.
Reporting these concerns to regulatory agencies and taking necessary actions, which may involve modifying prescribing recommendations or even withdrawing a drug from the market if deemed unsafe.
A Rewarding Career Path
Pharmacovigilance offers a fulfilling career option for pharmacists, other medical professionals, and even life science graduates. It allows them to directly contribute to public health by ensuring the safety and efficacy of medications used by millions.
The Ever-evolving Landscape of Drug Safety
While the focus remains on established medications, pharmacovigilance is particularly important for:
Newly launched drugs: Close monitoring is essential to identify any unforeseen side effects.
Long-term use of medications: Potential risks associated with extended use can come to light over time.
By continuously monitoring drug safety, pharmacovigilance plays a vital role in ensuring that medications provide the intended benefits with minimal risks.
Pharmacovigilance: A Lucrative Career Path for Pharmacists
While specific salary data can vary depending on the source, pharmacovigilance remains a highly attractive career option for pharmacists in 2024. Here's a breakdown with estimated ranges for entry-level to expert positions:
Entry-Level Pharmacovigilance Pharmacist: Starting salaries can range from around $50,000 to $75,000 annually. This range reflects roles focused on data collection, case processing, and basic reporting tasks (https://www.ziprecruiter.com/Salaries/Pharmacist-Salary).
Mid-Level Pharmacovigilance Pharmacist: With experience, pharmacists can progress to roles with greater responsibilities, such as data analysis, signal detection, and report writing. Salaries in this range can reach $80,000 to $100,000 annually (https://www.ziprecruiter.com/Salaries/Pharmacist-Salary).
Expert Pharmacovigilance Pharmacist: Pharmacists with extensive experience and specialized skills can command top salaries. Experts may lead teams, manage pharmacovigilance programs, or provide strategic oversight. Their compensation can exceed $120,000 and reach up to $150,000 or more annually (https://www.indeed.com/cmp/Indeed/salaries/Pharmacist).
Important Note: It's crucial to consider that salary figures can differ based on experience, location, specific job duties, and the size and type of employer (pharmaceutical company, contract research organization, etc.).
Beyond Dispensing: Pharmacists as Safety Guardians
The role of pharmacists has evolved significantly. They are no longer simply limited to dispensing medications. Pharmacovigilance offers a chance to directly impact public health by ensuring the safety and effectiveness of drugs used by millions.
A Focus on Drug Safety
Pharmacovigilance remains particularly important for:
New Medications: Close monitoring is crucial to identify any unforeseen side effects of recently released drugs.
Long-Term Use: Potential risks associated with extended use of medications can emerge over time.
By continuously monitoring drug safety, pharmacovigilance pharmacists play a vital role in ensuring patients receive the intended benefits of medications with minimal risks.
An Expanding Role for Pharmacists
Pharmacovigilance aligns perfectly with the changing role of pharmacists from medication dispensers to comprehensive healthcare providers. This specialized field allows pharmacists to leverage their expertise in medicine rationalization and patient safety to contribute significantly to the healthcare system.
Pharmacovigilance career in the USA
Alternative careers for pharmacists
Fig 2.2: career opportunities in pharmacovigilance
There is twenty thousand plus pharmacovigilance job in the USA. Most student graduates got a job as a pharmacy vigilance officer or drug safety officer in many pharmaceutical companies or healthcare clinics. People trained in pharmaceuticals also find pharmacovigilance pharmacist jobs in
• Pharmaceutical industries
• Contract research organization
• Biotech companies
• Regulatory authorities such as DCG, FDA, etc
The initial hiring of pharmacist usually based on their academic background
Some of the training programs that an individual can pursue before entering this industry and become a pharmacovigilance officer
• Learn more about Advanced Pharmacovigilance and Argus Safety Certification (APVASC)™
The drug safety clinic located in Sunnybrook health sciences center is a multidisciplinary clinic that focuses on the treatment of a patient having an adverse drug reaction. This clinic is recognized worldwide for the diagnosis and management of adverse effects of drugs.
Now, that clinic hires a part-time pharmacist for pharmacovigilance jobs to provide services in a clinical, research study or educational institutes of drug safety clinics. Many patients visit the clinic, and each patient has a consultation with one of the four physicians. Physicians then go through the history of patients, and most of the patients who visited the clinic have severe adverse effects, but some represent only mild allergic reactions.
Much research work regarding drug safety is also occurring in the clinic. Education is a significant component of the drug safety pharmacist. (Sandra et al., 2011)
Navigating the Frontiers of Pharmacovigilance: Enhancing Drug Safety and Public Health
Given the detailed discussion about the role of pharmacovigilance, drug safety officers, and career opportunities in the field, the following courses are recommended to be included within the content. These courses provide relevant training and certification opportunities for individuals aspiring to enter or advance in this field:
Pharmacovigilance Certification: Ideal for those starting out in pharmacovigilance or professionals looking to formalize their skills in drug safety monitoring and reporting.
Advanced Clinical Research Project Manager Certification: Suitable for those interested in overseeing pharmacovigilance projects and managing complex safety data.
Advanced Principal Investigator Physician Certification: For medical professionals who aim to lead clinical research and ensure adherence to safety protocols.
Medical Monitor Certification: Targets professionals who will monitor and evaluate clinical trial interventions for safety concerns.
References of note:
https://www.ashp.org/-/media/assets/policy-guidelines/docs/statements/role-of-medication-safety-leader.ashx: ASHP Statement on the Role of the Medication Safety Leader
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3053194/: Practice Spotlight: Drug Safety Pharmacist
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065524/: Why do we need pharmacists in pharmacovigilance systems?
https://psnet.ahrq.gov/primer/pharmacists-role-medication-safety: The Pharmacist's Role in Medication Safety
https://www.ziprecruiter.com/Jobs/Pharmacovigilance-Pharmacist: Pharmacovigilance Pharmacist Salary
Global Pharmacovigilance Regulations
Medicine is one of the most universal forms of healthcare. However, according to the American Society of Pharmacovigilance, adverse drug events alone are responsible for $13 billion in annual American healthcare costs. The U.S Department of Health and Human Services defines adverse drug events as undesirable consequences of taking certain medications, such as “medical errors, adverse drug reactions, allergic reactions, and overdoses”. It is internationally important that a medication is professionally assessed and monitored before it is deemed safe for consumers. This is where pharmacovigilance comes into play.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse effects. PV helps determine if a drug is safe for mass consumption before it is put on the market. In addition, PV ensures that if drugs with serious adverse drug reactions are pulled from the market. The field is an integral part in clinical research. In this article, we will explore the various agencies and regulatory bodies that supervise PV as well as clinical research. For those interested in becoming a pharmacovigilance expert, Pharmacovigilance Certification is available to guide you through the essentials of drug safety.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Created in 1990, the ICH connects global regulatory bodies and pharmaceutical companies to share technical innovations and discuss guidelines. The ICH GCP, or Good Clinical Practice, is one of the global governing clinical research guidelines for the EU, America, and Japan. Understanding and staying up to date with the ICH GCP is one of the most important qualifications someone could have before entering the clinical research industry. If you have any interest in clinical research and PV, CCRPS offers a free ICH GCP course that thoroughly explains and clarifies the complex document.
The European Medicines Agency (EMA): In the European Union (EU), the EMA coordinates PV and drug safety throughout all clinical trial phases. They ensure that a drug’s effects are monitored even after they are on the market. In addition to ICH GCP, the EU uses Good Pharmacovigilance Practice (GPvP) to determine monitoring standards of drug sales.
The Food and Drug Administration (FDA): In the United States (U.S.), the FDA supervises the approval of pharmaceutical products. Specifically, the Center for Drug Evaluation and Research or CDER is responsible for handling PV. Within CDER, the Office of Surveillance and Epidemiology assembles medical officers and safety evaluators to oversee PV in their field of experience. Most officers and evaluators are medical doctors or pharmacists.
Marketed Health Products Directorate (MHPD): The Canadian Directorate assesses and regulates health product risks. They are composed of 6 different bureaus and offices, each with their own area of speciality. Together, the Directorate monitors adverse drug effects and makes regulatory decisions.
Pharmaceuticals and Medical Devices Agency (PMDA): Established in 2004, the Japanese regulatory authority PMDA supervises the safety of drugs from the lab to the market. Not only do they consult clinical trial professionals on clinical compliance, they also provide post-market safety measures and relief services for adverse health effects.
Since drug safety is important for patient health and safety around the world, there are career opportunities for PV virtually anywhere. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. Our online Pharmacovigilance Certification guides new professionals to improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and flexible enough to fit any schedule. Moreover, for those looking to expand their career into clinical research coordination or clinical trials assistance, CCRPS offers comprehensive courses such as the Clinical Research Coordinator, Clinical Trials Assistant Training, CRA certification, Advanced Clinical Research Project Manager Certification, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification.
5 Step Guide to Becoming a Successful PV Professional
Pharmacovigilance (PV), also known as drug safety, is the study of a drug’s effects. It is a specialized department within clinical research and it has a lot of potential. PV professionals record and analyze a medicine’s adverse effects before and after its clinical development. Much like clinical research, PV is a largely under-explored field with great career prospects. According to reports, the pharmacovigilance market is expected to reach $12.98 Billion worldwide by 2027. The field has opportunities for all kinds of talents, including IT and statisticians. In this article, we will break down the PV field and outline educational requirements and career tips in 5 steps.
Enroll Instantly in our Pharmacovigilance Certification with 17.5 CME Credits
Step One: Undergraduate Degrees
Most positions in PV require some level of higher education. The pharmaceutical industry is highly regulated, and employers need to be sure that you have the necessary interest and knowledge before they make a hire.
Depending on what kind of career you want in your future, an associate’s degree or bachelor’s degree can help you get there. If you are interested in clinical positions, a bachelor’s in the life sciences or health-related studies will be highly desirable. If you are interested in non-clinical positions, such as those in IT or statistics, a computer science or mathematics degree will help get you there.
During this time, look for any direct opportunities to work in clinical research. University hospitals are a great place for research assistant or patient recruiter opportunities. The PV field is hard to break into, so building relevant experiences and making connections will help you tremendously in the future. Consider enhancing your resume with a Clinical Trials Assistant Training course.
Step Two: Graduate Degrees
Graduate programs may be of interest to those who want better career opportunities or specific positions, such as a PV physician. Health professionals with degrees such as MDs, DOs, RPhs, PharmDs, RNs, LPNs, DDS/DMDs, and DVMs can easily transfer their degrees and work experience into PV positions.
On the other hand, many pursue a master’s or a PhD because they increase one’s earning potential and open up more career opportunities. If you choose to get your degree, make sure to take advantage of your school’s resources and industry connections while you still have access to them. Advanced roles may benefit from specific certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification.
Step Three: Apply for Jobs
Here comes what many consider the hardest part of a PV career: breaking into the field. PV is a competitive field, and here’s how you stay ahead:
Highlight any direct clinical research experience and get a reference from your supervisor. This will be one of the best ways to grab an employer’s interest.
If you’ve taken a graduate PV program, take advantage of your school’s resources to help with placement and networking.
Join a professional association. Network and find out how practicing professionals landed their first job. Check the association job board for positions that may not be on other job boards.
Stay up to date and informed on field practices and trends. A way to demonstrate your enthusiasm and dedication is to take advantage of online courses. For example, CCRPS offers an affordable PV certification program as well as a free ICH GCP program. Both can help add to your resume.
Before you apply, polish your resume and prepare for questions. We have an in-depth article on how to ace your interview.
Plan your career ahead. We’ve done an article on how where you work can accelerate your career trajectory and help you obtain promoted faster.
Step Four: Work and Learn
PV is an ever-growing and innovative field. When you land your first job, be prepared to transition into the workforce and learn what you were not taught in the classroom.
As you work, take in the environment around you and contemplate your long-term goals. Some factors you should consider are:
What is the work culture like?
Do you have a mentor who can guide you through this career?
Does your work environment support your professional growth?
These questions can be important when you begin to apply for senior roles, especially if you are interested in line management roles. If you find that the company goals don't align with your own, it may be worth looking for a new position somewhere else.
Most importantly, as you settle into your new job, make sure that you continue to network and re-educate yourself on the field. The effort you invest in yourself will help you stand out to the right people. Consider taking a Medical Monitor Certification to further enhance your qualifications.
Step five: Applying for Senior Positions
When PV professionals have around 5-8 years of experience, most will apply for senior positions with better pay and benefits. Although senior positions tend to be very competitive, you will be equipped with years of experience and planning. When you are applying for senior positions, here are some aspects to consider:
Your work experiences and how they fit into the position you want. Consider what sets you apart from other applicants.
Your references should not only be able tell the employer your strengths, but also your weaknesses. While this might sound counterintuitive, hiring managers know that a reference that can’t speak about your weaknesses probably doesn't know you well enough to speak about your strengths. To them, an honest reference is the sign of a strong working relationship. This will help them infer the strength in your communications skills and work ethnic.
Your skills and qualifications should not only match the job description, they should demonstrate that you are going to be a valuable member of their team.
While navigating the PV field can be complicated, the process can be immensely rewarding. If you want to learn more about the PV field, visit CCRPS for more information on our courses and check out some of our other PV articles below.
How to Land a Career in PV
According to WHO, pharmacovigilance (PV) is the science of recognizing, analyzing, and preventing a drug’s adverse effects. It is an integral part of clinical research and drug safety. In this article, we will discuss PV’s career requirements and various specializations.
Education Requirements:
To join the PV field, you will need a bachelor's or graduate degree in medicine, pharmacy, nursing, or health sciences (ex: MD, DO, RPh, PharmD, RN, LPN, DDS/DMD, DVM) . A master’s or PhD will allow candidates to specialize and enjoy more employment opportunities. Some common PV specializations are:
data management
medical safety writing
quality management
compliance management
In addition to a formal education, you will also need direct experience in collecting, organizing, processing, and analyzing PV information. The field can be very data intensive, so having a background in data management or data mining can be a huge draw for employers.
How to land a position:
If you are looking for PV positions, you’ll notice that the most common employers are pharmaceutical companies, CROs, IT firms, KPOs, PV centers, and hospitals. Some great entry level positions are:
Pharmacovigilance Specialist (average salary: $68,995 )
Record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
Ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
Analyze data and compile them into reports.
Often responsible for management and leadership.
Explore Pharmacovigilance Careers: Unlock Opportunities in Drug Safety
List of Courses:
These courses are designed to enhance your qualifications and prepare you for a successful career in the dynamic field of pharmacovigilance. Whether you're starting out or looking to specialize further, explore these educational opportunities to advance your career in drug safety.
To employers, your qualification will be the number one factor that determines their hiring decision. PV is a highly technical field, and not having the skills or education you need can be disastrous for your job search. If you want to show your qualification and enthusiasm for the field, a great option would be getting PV certified. CCRPS’ online pharmacovigilance course helps new professionals improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and completely flexible to your schedule. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
How to Progress Your PV Career By Joining The Right Company
Pharmacovigilance (PV), or drug safety, is the study of a drug’s effects. Most importantly, PV monitors a drug’s adverse effects and protects consumers. PV professionals often find intellectually and financially fulfilling careers in the booming clinical research and pharmaceutical industry. Many start in the field in case management positions, but find it hard to access higher positions such as line management or technical specialists. Senior PV positions can be very competitive and difficult to acquire. However, doing research and planning ahead while you are applying for your first job can help you overcome these obstacles. Here are some tips on how to progress your career in PV.
Join the right company
When companies are hiring for senior positions, candidates must have the right qualifications and experience. However, critical experiences for higher positions can be hard to come by, especially in larger companies where case processing teams rarely work with senior level staff. When PV professionals feel that there aren't enough opportunities for growth in their work environment, one of the most effective strategies is to find and join a different kind of company. While this might seem drastic, making the change early can have lasting benefits on your career.
Here are ways your workplace shape your career:
Joining a smaller company and team will allow you to juggle more roles and gain the experience you need to apply for senior positions.
Joining a company where case processing occurs at the headquarter will allow you to work and network with more senior staff, which can prove extremely advantageous in the long run.
Joining a generics company could be the right move for you, especially if you are interested in senior technical roles. Since a generics company works with compounds that have expired patents and have been on the market for a considerable time, developing generic drugs carries less risk. Therefore, you are more likely to be promoted into signal detection work with less experience.
Joining regulatory or drug safety consultancies like CROs could also be smart for those interested in technical roles. They often offer job training for case processors to transition into signal detection roles. Additionally, since these companies specialize in outsourcing, working there would allow you to gain diverse product experiences and help your resume stand out.
Joining a health authority like the FDA or the EMA would allow you to read and analyze drug evaluations submitted by pharmaceutical companies. Your understanding on how to get approved by the regulatory bodies is a highly desirable skill set for pharmaceutical companies.
Advance Your Career in Pharmacovigilance: Navigating Opportunities in Drug Safety
List of Courses:
While applying for senior PV positions can be competitive and difficult, there are many ways for starting professionals to build their credentials while having an unique and fulfilling career. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. We offer an online pharmacovigilance course to help new professionals improve their qualifications and gain expert insight in the field. The course is curated by real clinical research professionals and perfect for a busy schedule.
Pharmacovigilance Positions and Careers in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care annually. Thus, it is paramount that drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialities to ensure that a drug is safe and tested before it is consumed by the masses. In this article, we will look at the different ways PV professionals contribute to drug safety in clinical research settings.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines if a drug is ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase will involve more subjects and be more risky. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or have major repercussions such as causing disabilities in the patient or inducing birth defects. On the other hand, ADR is an adverse drug reaction. ADRs include a drug’s milder side effects, like headaches, nausea, or fatigue. The safety data collected by the operations division is key to determining a drug’s use and safety.
In addition to data collection, the operations team is responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drug is on the market.
The safety data collected by the operations division is maintained by the PV systems division. They ensure that an immense amount of data is organized and accessible to research collaborators. The systems team is always working to improve and maintain safety data, since field regulations and industry expectations are always changing.
After being organized by the systems division, the safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their insights into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical trials. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org.
For those who are considering further specialization within clinical research, opportunities such as becoming a Clinical Research Coordinator, CRA, or a Clinical Trials Assistant are also available. These roles are critical in the management and execution of clinical trials and offer a pathway to advanced positions like Advanced Clinical Research Project Manager Certification or an Advanced Principal Investigator Physician Certification.
For medical professionals looking to expand their expertise in overseeing clinical trial safety and compliance, our ICH-GCP course and Medical Monitor Certification provide comprehensive training in Good Clinical Practice and the responsibilities of a medical monitor in clinical research.
Top 7 Words Every Pharmacovigilance Professional Should Know
7 Key Terms You Need to Know
In the dynamic world of clinical research, ensuring medication safety throughout a drug's lifecycle is paramount. Pharmacovigilance (PV) stands as the guardian of this mission. But navigating this field requires fluency in its specific language. Here's a breakdown of 7 crucial terms every PV professional should understand in 2024, along with valuable resources to empower your journey:
1. Adverse Drug Reaction (ADR): Any unintended effect of a drug, regardless of severity or dosage. All ADRs are documented and evaluated for regulatory purposes.
Reference: Council for International Organizations of Medical Sciences (CIOMS) I Working Group III: A glossary of terms used in pharmacovigilance. Br J Clin Pharmacol. 1999;47(2):835-7. PubMed: https://pubmed.ncbi.nlm.nih.gov/10434043/
2. Side Effect: An unintended but expected consequence of a drug at the recommended dosage. Side effects differ from ADRs as they are anticipated outcomes of the medication.
Reference: Good Clinical Practice: E6(R2). International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. November 2016. Available online at ICH website: https://www.ich.org/
3. Adverse Drug Event (ADE): Defined by the International Council for Harmonisation (ICH) as any unfavorable medical experience during a patient's medication use. Unlike ADRs, ADEs don't necessarily imply a causal relationship with the drug.
Reference: International Council for Harmonisation (ICH) Guidance for Industry E6(R2) Good Clinical Practice: ICH Topic E6. Available online at ICH website: https://www.ich.org/
4. Serious Adverse Event (SAE): A severe medical reaction to a drug at any dose, including life-threatening situations, hospitalization, disability, or birth defects. PV professionals assess reported events to determine if they meet SAE criteria.
Reference: ICH Topic E6(R2) Section 4.8 Definitions and Abbreviations. Available online at ICH website: https://www.ich.org/
5. Unexpected Adverse Drug Reaction (USADR): An ADR not previously documented in the drug's local labeling. If a USADR is also serious or life-threatening, it becomes a Suspected Unexpected Serious Adverse Reaction (SUSAR). These occurrences require prompt reporting to regulatory bodies by PV teams.
Reference: Regulation (EU) No 1381/2007 of the European Parliament and of the Council of 20 November 2007 on the transparency of medicinal products for human use and amending Directive 2001/83/EC, Council Regulation (EC) No 2587/95 and Directive 2004/27/EC. Europa.eu website: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32007R1381
6. Signal Detection: A cornerstone of pharmacovigilance. PV professionals leverage data analysis tools to identify trends and deviations from expected patterns in drug safety data. Signals may indicate a new, potential drug effect, either beneficial or adverse.
Reference: World Health Organization (WHO) Guidelines for Standardized MedDRA Coding and Use in Pharmacovigilance. WHO website: Although not directly related to signal detection, this is a relevant WHO resource: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
7. Causality Assessment: The process of determining the likelihood that a drug caused a reported ADE. This assessment helps PV professionals establish the level of association between the medication and the adverse event. Causality assessments can range from:
Certain: There is clear and convincing evidence that the drug caused the ADE.
Probable/likely: It is more likely than not that the drug caused the ADE.
Possible: There is a chance that the drug caused the ADE, but other factors could also be responsible.
Unlikely: It is improbable that the drug caused the ADE.
Conditional/unclassified
In addition, if you want to be more qualified in the field of clinical research, you may want to consider getting certified in several key areas. A great starting point is the CCRPS’ online pharmacovigilance course, which helps new professionals improve their qualifications and gain expert insight in the field. This course is curated by real clinical research professionals and is flexible to your schedule.
If you’re aiming to further enhance your career, CCRPS offers a variety of specialized courses tailored to different roles within clinical research. Those interested in coordinating clinical trials might consider the Clinical Research Coordinator course. For those looking to oversee clinical trial conduct, the CRA (Clinical Research Associate) course is ideal.
Aspiring clinical trials assistants who support clinical research sites can benefit from the Clinical Trials Assistant Training. If you are pursuing leadership roles in clinical research projects, the Advanced Clinical Research Project Manager Certification might be the right choice.
For physicians who wish to lead clinical studies, the Advanced Principal Investigator Physician Certification can provide the necessary expertise. Furthermore, individuals interested in ensuring the safety and efficacy of clinical trials may find the Medical Monitor Certification extremely useful.
Finally, to stay compliant with international standards in clinical research, consider our ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) course, which is crucial for anyone involved in global clinical research.
To explore these courses and learn more about how they can enhance your career in clinical research, please visit our website at CCRPS.Org.
What is Pharmacovigilance (PV)
According to the American Society of Pharmacovigilance, every year 1 million emergency department visits, 2.2 million hospital admissions, and 3.5 million physician office visits are caused by adverse drug effects. To prevent these tragedies, there is a special department in clinical research called pharmacovigilance. Pharmacovigilance, or drug safety, is the study of a drug’s adverse effects. PV professionals determine a drug’s safety and effectiveness before it is released into the market.
PV is a vast and complex discipline that requires diverse skill sets. Some roles may require administrative expertise, while others require firm understanding of statistics. Regardless, the PV department’s teams and divisions all collaborate towards one goal: to improve drug safety. Some common PV positions include:
Pharmacovigilance Specialist (average salary: $68,995 )
They record and report a drug’s adverse events after it has been on the market
Pharmacovigilance Associate (average salary: $90,557)
They ensure that clinical trials developments are following regulatory compliance.
Pharmacovigilance Scientist (average salary: $123,499)
They analyze data and compile them into reports. They are also often responsible for management and leadership.
Although there are many different positions within PV, many share common responsibilities such as:
Medical evaluation,
Assessment of expectedness and drug-ADR associations,
Casualty assessment,
Case narratives and processing,
Use of medical dictionaries,
Data mining and signal detection,
Medication error related activities
Specialized services (writing, compliance, global PV, ect)
To work in PV, you need at least a bachelor’s degree in the health sciences as well as relevant experience. Many professionals from nursing, pharmacy, and medicine find successful careers in PV. However, it is a competitive field. In PV, technical qualifications and a well rounded understanding of the human body are everything. At CCRPS, we offer a pharmacovigilance certification course that will help you better understand the industry and improve your qualifications.
Explore Career Advancements in Pharmacovigilance
Pharmacovigilance Certification
This certification will equip you with the necessary skills to effectively manage and report adverse drug reactions and ensure compliance with regulatory laws.
Clinical Research Coordinator Certification
Learn the fundamentals of clinical research coordination, enhancing your ability to manage clinical trials and patient care effectively.CRA Certification
As a Clinical Research Associate, gain expertise in monitoring clinical trials and ensuring adherence to established guidelines and regulations.ICH-GCP Certification
This certification provides thorough training in the International Conference on Harmonisation - Good Clinical Practice guidelines, crucial for anyone involved in clinical trials.Clinical Trials Assistant Training
Prepare for a role as a Clinical Trials Assistant, where you will support the administration and operational aspects of clinical trials.Advanced Clinical Research Project Manager Certification
Develop advanced skills in managing complex research projects, overseeing trial progress, and ensuring projects meet their objectives.Advanced Principal Investigator Physician Certification
This course is designed for physicians who wish to lead clinical trials, focusing on the intricacies of trial management and regulatory compliance.Medical Monitor Certification
Gain specialized skills in monitoring and overseeing the medical aspects of clinical trials, ensuring patient safety and the integrity of clinical data.
What is the Role of Pharmacovigilance in Clinical Research
What is Pharmacovigilance?
Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events annually account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care costs. Thus, it is paramount that these drugs are as safe they can be.
Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialties to ensure that a drug is safe and tested before it can be consumed by the masses.
Why is PV Important?
A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines what drugs are ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase involves more people and more risk. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.
What Roles are in PV?
In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or cause disabilities in the patient or induce birth defects. On the other hand, ADR is an adverse drug reaction, which is a milder adverse reaction to a drug. They include conditions like headaches, nausea, or fatigue.
In addition to data collection, operations are responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drugs are on the market. Those interested in a deeper dive into standard operating procedures and case studies might consider exploring the ICH-GCP course.
The safety data collected by the operations division is maintained by those in the PV systems. They ensure that the data is organized and accessible to research collaborators. The systems team is always working to improve and maintain the vast data, since field regulations and expectations are always changing.
The safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their analysis into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical research. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval. Professionals aiming to oversee such critical roles in drug safety might be interested in the Advanced Clinical Research Project Manager Certification.
How Do I Start?
The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org and chec.
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