PV Pharmacoepidemiologist
Scientific · Industry · Data Collection Schemes
Conducts pharmacoepidemiologic studies and reviews to support drug safety.
Also known as: PV Epidemiologist Researcher, PV Research Fellow
This competency standard is a working draft prepared for reviewand is not yet an official GPPC standard. Content is derived from the role’s job description and established pharmacovigilance practice, and is subject to change.
Job description
- Responsible for managing pharmacoepidemiologic projects and activities with limited direction in support of marketed products in accordance with global regulations the and company's SOPs and working practices.
- Serve as a subject matter expert on pharmacoepidemiology for assigned marketed/development compound(s) and to other divisions.
- Keep up to date with the latest epidemiologic methods and resources, to be able to be responsive within cross-functional teams and to guide decision making where needed.
- Responsible for implementation of pharmacoepidemiology strategy, generation of RWE, the conduct of regulatory agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, the effectiveness of REMS and RMMs).
- Provide a critical review of relevant published literature.
- Build and maintain effective partnerships with Medical Affairs, Clinical Development, and Regulatory Affairs departments.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the PV Pharmacoepidemiologist role. As a scientific role, intermediate-to-expert command of the relevant scientific domain and its regulatory context is expected. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →University degree in medicine, pharmacy, life sciences or a related discipline
- →Relevant pharmacovigilance experience appropriate to the role
Recommendations
- →Working proficiency in English
- →Familiarity with the applicable GVP modules
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance principles and Good Pharmacovigilance Practices (GVP) overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems; EU Reg (EC) 726/2004 & Dir 2001/83/EC | Intermediate |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Intermediate |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Intermediate |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| Pharmacoepidemiology study design (PASS/PAES)Ref: EMA GVP Module VIII (Rev 3); ENCePP Guide on Methodological Standards | Expert |
| Real-world evidence (RWE) and data sourcesRef: ENCePP Guide on Methodological Standards in Pharmacoepidemiology | Intermediate |
| Biostatistics and study analysis | Intermediate |
| GVP Module VIII (post-authorisation safety studies)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Intermediate |
| Risk management planning (GVP Module V): RMP structure and lifecycleRef: EMA GVP Module V — Risk management systems (Rev 2) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Basic |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| Budgeting, resourcing and business continuity | Intermediate |
| Post-authorisation safety studies (PASS/PAES)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Study design |
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| Analysis |
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| Evidence |
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Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
