Global Patient Safety Senior Manager - Signal & Strategy

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health & wellness programs

401(k) company match

Annual bonuses

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Manager of Global Patient Safety to lead safety strategies for molecules in clinical development and post‑marketing. You will aggregate, review, and analyze safety data to support benefit-risk assessments, and manage risk management activities across assigned compounds.

The role requires a strong background in pharmacovigilance, regulatory guidelines, and experience with safety databases.

Qualifications

• Master’s, PhD, or PharmD required.
• 7+ years risk management in pharma/biotech or health authority.
• Ability to apply FDA, EU, and ICH pharmacovigilance guidelines.
• Experience with safety system databases and medical case review.

Responsibilities

• Perform signal detection activities as per safety surveillance plan.
• Evaluate signals and write safety evaluation reports.
• Prepare/review DSUR, PSUR, and RMP; respond to queries from authorities.
• Prepare and present at SMT meetings; participate in study team meetings.
• Engage in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC, etc.).
• Contribute to SOPs, WIs, and supporting documents.

Skills

Safety data analysis

Regulatory knowledge

Communication skills

Time management

Education

Master’s/PhD/PharmD

Job description

Regeneron Pharmaceuticals, Inc (USA) seeks a Senior Manager of Global Patient Safety to lead safety strategies for molecules in clinical development and post‑marketing. You will aggregate, review, and analyze safety data to support benefit-risk assessments, and manage risk management activities across assigned compounds.

The role requires a strong background in pharmacovigilance, regulatory guidelines, and experience with safety databases.