Senior Global Patient Safety Lead

Regeneron Pharmaceuticals, Inc.; Kentucky; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety (GPS) to play a key scientific role in safety strategies for molecules in clinical development and post-marketing stages.

You will aggregate, review, and analyze safety data to support interpretation and benefit-risk assessments, contributing to a fast-growing, science-driven organization that helps patients worldwide.

Qualifications

• Master's, PhD, or PharmD (terminal degree) required.
• 10+ years of relevant risk management experience in pharma/biotech.
• 8–10+ years of risk management or clinical experience in pharma/biotech.
• Knowledge of FDA/EU/ICH pharmacovigilance guidelines.
• Experience with safety systems databases for medical review and queries.
• Strong communication of safety findings (verbal and written).

Responsibilities

• Conduct signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare/review DSUR, PSUR, and risk management plans; respond to authorities.
• Present at SMT meetings and participate in clinical study team meetings.
• Engage in cross-functional teams (RSOC, IDMC) as needed.
• Provide medical review for assigned compounds and contribute to SOPs and supporting docs.

Skills

Risk management

Safety evaluation

Communication skills

Clinical/pharma experience

Education

Master's degree

PhD

PharmD

Tools

Safety database systems

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director for Global Patient Safety (GPS) to play a key scientific role in safety strategies for molecules in clinical development and post-marketing stages.

You will aggregate, review, and analyze safety data to support interpretation and benefit-risk assessments, contributing to a fast-growing, science-driven organization that helps patients worldwide.