Medical Reviewer
Scientific · Industry · Data Management
Provides medical oversight of individual case safety reports — seriousness, expectedness, causality, coding and narratives.
Also known as: Medical Record Reviewer, Medical Document Reviewer, Clinical Reviewer
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
- Lead the medical review — including seriousness, expectedness/listedness, causality, coding, and narratives — of individual case safety reports for medical completeness, accuracy, and overall medical content, for assigned investigational and marketed products.
- Direct medical oversight including literature review for individual case safety reports.
- Lead and direct the preparation, authoring, and approval of analysis of similar events for expedited case 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, evaluate the coding and labelling, and confirm the events are evaluated correctly.
- Lead and direct medical oversight and guidance to vendors performing case processing, including required training.
Overall required level: Intermediate.The Medical Reviewer is expected to hold intermediate-to-expert knowledge of individual case safety report assessment, medical coding and causality, with a strong command of case-processing regulations.
Prerequisites
Mandatory prerequisites
- →Medical or pharmacy degree (or equivalent clinical qualification)
- →Experience in case processing or safety review
Recommendations
- →Working proficiency in English
- →MedDRA coding familiarity
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 GVP overview | Intermediate |
| ICH E2A/E2B — expedited reporting and data elements | Expert |
| ICSR lifecycle and case processing | Expert |
Role-Specific Knowledge
| Topic | Level |
|---|---|
| Seriousness, expectedness and causality assessment | Expert |
| MedDRA coding and medical coding reconciliation | Expert |
| Case narratives and follow-up correspondence | Intermediate |
| Analysis of similar events (AOSE) | Intermediate |
| Reference safety information and labelling assessment | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Case assessment |
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| Medical coding |
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| Safety issue management |
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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.
