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About the Role
The Mid-Level Safety Physician will independently manage safety activities across clinical and marketed products, contributing to risk management strategies and global regulatory submissions.
Key Responsibilities
Lead signal detection, validation, and evaluation
Author and review aggregate reports (PSUR, DSUR, PBRER)
Support Risk Evaluation and Mitigation Strategies (REMS)
Provide medical input for regulatory submissions
Act as medical safety advisor for cross-functional teams
Requirements
MD with 5–10 years of experience in Drug Safety / PV
Strong experience in aggregate reporting and signaling
Knowledge of REMS and global regulatory requirements
Experience working with global CROs or sponsors
Ability to work independently and mentor junior staff
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