PV Medical Assessor
Scientific · Regulatory Authority
Performs medical assessment of safety data within a regulatory authority.
Also known as: PV Medical Officer, Pharmaceutical Assessor
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
- Provide administrative oversight of medical review activities.
- Perform review and evaluation of causality assessment of adverse events in individual case safety reports.
- Author scientific publications on behalf of the regulatory authority.
- Contribute to transparency and communication initiatives through the provision of scientifically rigorous and consistent information to promote the safe and effective use of medicines.
- Liaise with and provide technical information, advice, and guidance on relevant PV matters to other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public.
- Participate at all levels (internally and externally) in the formulation and preparation of regulatory policies, guidelines, legislation, and opinions.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the PV Medical Assessor 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 |
|---|---|
| PV legislation and regulatory assessment proceduresRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
| Assessment of causality, signals and aggregate dataRef: EMA GVP Module IX; GVP Module VII | Expert |
| Regulatory action and risk communicationRef: EMA GVP Module XV — Safety communication (Rev 1) | Intermediate |
| Nomenclature and coding standardsRef: MedDRA (MedDRA MSSO); ISO IDMP standards | Intermediate |
| ICSR lifecycle: receipt, triage, data entry, quality controlRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Intermediate |
| Medical review of ICSRs: seriousness, expectedness, causalityRef: EMA GVP Module VI (Rev 2); ICH E2A — Clinical Safety Data Management | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Assessment |
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| Regulatory action |
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| Communication |
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Get certified for this role
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.
