Senior Associate Director, Global Patient Safety

Regeneron Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join Global Patient Safety, leading safety strategies for molecules in clinical development and post‑marketing programs.

You will perform signal detection/evaluation, prepare DSUR/PSUR/RMP, and present findings at SMT while collaborating with cross‑functional teams. The role emphasizes risk management, regulatory compliance, and medical review, with on‑site work at multiple locations and potential travel.

Qualifications

• Minimum a Master’s, PhD, or PharmD (Terminal Degree preferred)
• Offers 10+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post‑marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple query
• Able to be proactive and self‑disciplined, you can meet deliverables, and effectively use your time and prioritize
• Ability to effectively communicate (verbal and written) safety findings
• Provide a background that includes: Master’s, PhD, or PharmD
• Clinical experience and/or industry experience in the TA of interest is a plus

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross‑functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Resource for medical review of assigned compounds
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Skills

Risk management

Pharmacovigilance

Safety data analysis

Medical writing

Education

Master’s

PhD

PharmD

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join Global Patient Safety, leading safety strategies for molecules in clinical development and post‑marketing programs.

You will perform signal detection/evaluation, prepare DSUR/PSUR/RMP, and present findings at SMT while collaborating with cross‑functional teams. The role emphasizes risk management, regulatory compliance, and medical review, with on‑site work at multiple locations and potential travel.