Principal Scientist, Drug Safety

About the role

The CSRM Physician, Principal Scientist leads clinical risk management and safety surveillance for investigational and marketed products. Reporting to senior CSRM leadership, the role chairs the Risk Management and Safety Team and collaborates globally across Clinical Development, Regulatory Affairs, and other functions.

Key responsibilities

• Serve as a core member of product development teams, chairing the RMST and ensuring robust safety assessments.
• Lead safety surveillance activities, evaluate data from trials, literature, and post‑approval use, and manage signal detection.
• Develop and maintain risk management and pharmacovigilance plans, and provide scientific strategy for safety‑related regulatory documents.
• Collaborate cross‑functionally to align safety activities with global strategies and communicate benefit‑risk considerations.

Required profile

• MD, DO, or equivalent medical degree; board certification preferred.
• Minimum 3 years of clinical experience after postgraduate training, preferably in pharmacovigilance or drug safety.
• Excellent communication, analytical, and organizational skills with ability to apply sound medical judgment.

Required skills

• Clinical Development
• Clinical Risk Management
• Clinical Safety
• Cross‑Functional Project Management
• Medical Review
• Medical Writing
• Pharmacovigilance
• Risk Management
• Safety Evaluation
• Safety Strategy
• Scientific Leadership

What we offer

• Competitive salary range $231,900 – $365,000 per year.
• Annual bonus and long‑term incentive eligibility.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.