Global Patient Safety Lead - Ophthalmology

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Paid time off

Global wellness programs

401(k) company match

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director in Global Patient Safety (GPS) to lead safety strategies for molecules in development and post‑marketing. The role involves safety data aggregation, risk assessment, and preparation of safety reports while collaborating with cross‑functional teams across regions.

The candidate should have 10+ years in risk management within pharma/biotech, with deep experience in regulatory guidelines and safety systems. On‑site work at multiple U.S.

Qualifications

• Minimum a Master’s, PhD, or PharmD (terminal degree preferred).
• 10+ years of risk management experience in pharma/biotech or health authority.
• 8–10+ years of risk management or relevant clinical experience in pharma/biotech/health authority.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance in clinical trial and post‑marketing settings.
• Ability to work with a safety system database for medical case review and basic queries.

Responsibilities

• Perform signal detection activities in line with the safety surveillance plan.
• Evaluate signals and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and respond to inquiries.
• Deliver presentations at SMT meetings and participate in study team meetings.
• Engage in risk management activities and contribute to SOPs and supporting documents.

Skills

Safety risk management

Signal detection

FDA/EU/ICH guidelines

Clinical safety experience

Communication (written)

Education

Master's degree / PhD / PharmD

Tools

Safety database

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director in Global Patient Safety (GPS) to lead safety strategies for molecules in development and post‑marketing. The role involves safety data aggregation, risk assessment, and preparation of safety reports while collaborating with cross‑functional teams across regions.

The candidate should have 10+ years in risk management within pharma/biotech, with deep experience in regulatory guidelines and safety systems. On‑site work at multiple U.S.