Global Patient Safety Lead

Regeneron Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team.

The role focuses on safety strategies for molecules in clinical development and post-marketing, including data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment. The position involves on-site work locations in Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA, with 4 days on-site and 25% travel; you will contribute to safety strategies, author safety

Qualifications

• Minimum Master degree, PharmD, PhD.
• 5+ years of risk management or relevant clinical experience in pharma/biotech or health authority.
• Clinical experience in the therapeutic area is a plus.
• Ability to apply FDA, EU and ICH pharmacovigilance guidelines and regulations.

Responsibilities

• Complete signal detection activities per the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP, health authority responses).
• Prepare and deliver SMT presentations; participate in clinical study team meetings for assigned compounds.

Skills

Data analysis

Safety surveillance

Cross-functional collaboration

Communication

Education

Master's degree

PharmD

PhD

Tools

Excel

Pivot tables

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team.

The role focuses on safety strategies for molecules in clinical development and post-marketing, including data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment. The position involves on-site work locations in Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA, with 4 days on-site and 25% travel; you will contribute to safety strategies, author safety