CSRM Physician - Senior Principal Scientist, Drug Safety
Merck · Rahway, NJ +1 more
SafetyFull-time$282k–$444kCompany career page
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Role summary
Senior Principal Scientist physician leader for pharmacovigilance at Merck, responsible for clinical risk management and safety surveillance of investigational and marketed products. Chairs Risk Management Safety Teams and guides development of comprehensive risk management and pharmacovigilance strategies across product portfolios.
What they're looking for
- MD, DO, or equivalent medical degree
- Minimum 3 years post-graduate clinical experience or relevant clinical background
- Prior experience in drug development, clinical development, and/or regulatory affairs
- Demonstrated expertise in clinical safety, pharmacovigilance, and risk management
- Leadership experience in clinical or safety-related organizational settings
- Strong communication, writing, and analytical capabilities
- Proficiency in FDA submissions, safety reporting, and MedDRA
What you'll be doing
- Lead Risk Management Safety Teams and chair product development team safety committees
- Develop and maintain risk management plans, pharmacovigilance plans, and periodic safety update reports
- Evaluate safety data from clinical trials, literature, and post-approval surveillance to inform risk assessments
- Direct safety surveillance activities including aggregate data analysis and post-approval safety signaling reviews
- Make recommendations on labeling, risk minimization activities, and pharmacovigilance actions
Privacy & handoff
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