Global Patient Safety Manager: Signals & Risk Analytics

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Manager of Global Patient Safety to lead safety strategies during clinical development and post‑marketing. You will aggregate and analyze safety data to support benefit‑risk assessments and regulatory interactions.

Responsibilities include signal detection/evaluation, DSUR/PSUR/RMP preparation, and presenting to SMT. Collaboration across study teams and RSOC/IDMC is expected, with a focus on data‑driven safety insights.

Qualifications

• Master of science, PhD or PharmD required.
• 5+ years in risk management or clinical safety in pharma/biotech or health authority.
• Clinical or industry experience in the therapeutic area of interest is a plus.

Responsibilities

• Complete signal detection activities per the safety surveillance plan.
• Evaluate signals and author safety evaluation reports.
• Prepare and review DSUR, PSUR, RMP and health authority responses.
• Present at SMT meetings; participate in clinical study team meetings.
• Contribute to other risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC, etc.).
• Utilize Excel/Pivot for safety data manipulation and analysis.
• Support process improvements and maintain SOPs and WIs.

Skills

Safety experience

Clinical experience

Education

Master of science, PhD, or PharmD

Tools

Excel

Pivot tables

Job description

Regeneron Pharmaceuticals, Inc (USA) seeks a Manager of Global Patient Safety to lead safety strategies during clinical development and post‑marketing. You will aggregate and analyze safety data to support benefit‑risk assessments and regulatory interactions.

Responsibilities include signal detection/evaluation, DSUR/PSUR/RMP preparation, and presenting to SMT. Collaboration across study teams and RSOC/IDMC is expected, with a focus on data‑driven safety insights.