Consultant, Pharmacovigilance, PSUR/PBRER Writing
France
Full Time
6 hours ago
Key skills
VaultCollaborationRemote Work
About this role
Role Overview
- Lead and author PSURs/PBRERs in compliance with ICH E2C(R2) requirements and GVP Module VII
- Coordinate cross-functional contributors
- Perform cumulative safety data analyses and integrated benefit–risk assessments
- Draft strategic sections (Signal & Risk Evaluation, Integrated Benefit–Risk Analysis, RSI updates, etc.)
- Ensure scientific consistency with the CCDS, RSI (SmPC) and the RMP
- Ensure compliance with regulatory timelines and the quality of deliverables
- Contribute to responses to regulatory authorities and requests for additional information
Requirements
- Strong background in pharmacovigilance
- Proven expertise in writing and managing PSURs/PBRERs
- Minimum 2 to 5 years' experience in the pharmaceutical industry or in a CRO
- Excellent knowledge of ICH E2C(R2) guidelines
- Thorough knowledge of GVP Module VII
- Structured, analytical scientific writing skills
- Critical analysis of post-marketing safety data
- Proficiency with pharmacovigilance databases (Argus, ARISg, Veeva Vault Safety, etc.)
- Professional-level English required
Tech Stack
- Vault
Benefits
- Stimulating work environment
- Collaboration with passionate experts
- Remote work possible