← Career Framework
ScientificS.I.SM.ME
Medical Evaluator
Scientific · Industry · Signal Management
Leads medical review of aggregated safety reports and prepares benefit/risk sections.
Also known as: Medical Review Evaluator, Clinical Evaluator, Medical Care Evaluator, Medical Liaison
Draft
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
- Implement risk mitigation activities, prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds.
- Participate as a member of the matrix teams to address product-specific safety issues, assist in the development of signal evaluation strategies, and participate in signal evaluation.
- Lead the medical review, including seriousness, expectedness/listedness, causality, coding, and narratives of aggregated safety reports for medical completeness, accuracy, and overall medical content, for the assigned investigational and marketed products.
- Direct medical oversight including literature review for aggregated safety reports.
- Manage the review of cases according to internal timelines.
- Contribute to solving reconciliation medical coding issues/discrepancies.
- Review and update generated follow-up letters for the reporters and investigators as appropriate.
- Identify, communicate, and effectively manage potential safety issues.
- Review the Line Listings and evaluate the coding and labelling, confirming that the events are evaluated correctly.
- Lead and direct the medical input and guidance for ad-hoc queries for aggregated cases.
- Lead and direct medical oversight and guidance to vendors performing case processing.
- Lead and implement with alliance partners harmonization and industry-standard medical review and case assessment standards.
- 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 Medical Evaluator 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 |
|---|---|
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Expert |
| Signal detection methodologies and disproportionality analysisRef: EMA GVP Module IX Addendum I (methodological aspects of signal detection); CIOMS Working Group VIII | Expert |
| Signal validation, assessment and prioritisationRef: EMA GVP Module IX — Signal management (Rev 1) | Intermediate |
| Aggregate safety data sources and their limitationsRef: CIOMS Working Group VIII — Practical Aspects of Signal Detection in Pharmacovigilance (2010) | Intermediate |
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
| MedDRA and WHODrug coding conventionsRef: MedDRA (MedDRA MSSO); WHODrug (Uppsala Monitoring Centre) | 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 |
| 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 |
| Vendor governance and outsourcing oversightRef: EMA GVP Module I (outsourced activities) | Intermediate |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Detection |
|
|
|
| Assessment |
|
|
|
| Reporting |
|
|
|
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.
