Global Patient Safety Strategy Lead

Regeneron Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to join Global Patient Safety. This role leads signal detection, safety evaluation, and preparation of DSUR, PSUR, and RMP documents for molecules in clinical development and post-marketing.

You will present at SMT meetings, collaborate across functions, and contribute to risk management activities while ensuring compliance with FDA, EU, and ICH guidelines. On-site work at Tarrytown, NY or Warren, NJ four days per week.

Qualifications

• Masters/PhD/PharmD required or equivalent.
• Extensive risk management experience in pharma/biotech or health authority.
• Knowledge of FDA/EU/ICH guidelines for pharmacovigilance.

Responsibilities

• Signal detection activities.
• Author safety evaluation reports.
• Prepare DSUR/PSUR/RMP and respond to health authority queries.
• Deliver presentations at SMT meetings and participate in cross-functional teams.

Skills

Signal detection

Safety evaluation

Regulatory submissions

Presentations

Education

Master's degree

PhD

PharmD

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to join Global Patient Safety. This role leads signal detection, safety evaluation, and preparation of DSUR, PSUR, and RMP documents for molecules in clinical development and post-marketing.

You will present at SMT meetings, collaborate across functions, and contribute to risk management activities while ensuring compliance with FDA, EU, and ICH guidelines. On-site work at Tarrytown, NY or Warren, NJ four days per week.