Manager, Global Patient Safety Scientist

Regeneron seeks a Manager, Global Patient Safety Scientist to lead safety strategy and analysis for molecules in clinical development and post-marketing phases. The role involves signal detection, safety evaluation, and preparation of regulatory documents to support benefit-risk assessment across a portfolio of compounds.

Responsibilities

• Conduct signal detection activities aligned with approved safety surveillance plans
• Evaluate identified signals and author comprehensive safety evaluation reports
• Prepare and review safety documents including DSUR, PSUR, RMP, and health authority responses
• Present findings at Signal Management Team meetings and participate in clinical study team discussions
• Contribute to risk management activities and cross-functional oversight committees

Requirements

• Master's degree, PharmD, or PhD
• Minimum 5+ years of risk management or clinical experience in pharmaceutical or biotech industry
• Knowledge of FDA, EU, and ICH guidelines for pharmacovigilance in clinical and post-marketing settings
• Proficiency with safety database systems for medical case review and queries
• Advanced data manipulation and visualization skills using Excel and pivot tables
• Strong verbal and written communication of complex safety findings
• Self-directed with ability to prioritize and meet multiple deliverables

Compensation: $114,800–$187,400 base annually