Position Details
About this role
Associate Pharmacovigilance Scientist supports the Safety Surveillance and Aggregate Report (SSA) team, handling signal management, aggregate report preparation (PSURs/DSURs), and regulatory responses for marketed/investigational products. The role includes literature reviews, ICF/AE coding activities, and cross-functional collaboration.
Key Responsibilities
- Supports Signal Management activities; supports updates to RMPs; collaborates with Global Safety Officers; represents SSA in cross-functional meetings; performs ICF review, AE coding review and other clinical trial safety-related activities; conducts literature review; prepares aggregate reports such as PSURs, DSURs
Technical Overview
Emphasizes PV processes including signal management, PSUR/DSUR preparation, RMP updates, and data verification with cross-functional collaboration across regulatory and clinical development.
Ideal Candidate
The ideal candidate is a mid-level pharmacovigilance professional with 3+ years PV experience and a strong background in signal management, PSUR/DSUR preparation, and cross-functional collaboration to ensure patient safety and regulatory compliance.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
less than 3 years PV experience, no exposure to PSUR/DSUR, no Bachelor’s degree in relevant science
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