Global Patient Safety: Associate Director

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 176,000 - 287,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks an Associate Director for Global Patient Safety to lead safety strategies for assets in clinical development and post-marketing. You will oversee signal detection, evaluation, and documentation, contributing to benefit-risk assessments and safety data interpretation across programs.

You will collaborate with cross-functional teams, prepare DSUR/PSUR/RMP documents, and present findings to SMT.

Qualifications

• Master's, PhD, or PharmD (Terminal Degree preferred)
• 10+ years in risk management in pharma/biotech or health authority
• Experience in pharmacovigilance for clinical and post-marketing environments; FDA/EU/ICH guidelines

Responsibilities

• Complete signal detection activities per safety surveillance plan
• Evaluate identified signals and author safety evaluation reports
• Prepare and review DSUR, PSUR, and RMP documents
• Deliver presentations at SMT meetings and participate in study teams
• Contribute to risk management activities for assigned compounds
• Represent GPS on cross-functional teams and safety committees
• Assist in process improvements and SOP/WI development

Skills

Signal detection

Safety evaluation

Regulatory documents

Cross-functional collaboration

Regulatory guidelines

Medical review

Communication

Project management

Leadership

Education

Master's/PhD/PharmD

Tools

Safety database

Regulatory submissions system

Job description

Regeneron Pharmaceuticals, Inc (USA) seeks an Associate Director for Global Patient Safety to lead safety strategies for assets in clinical development and post-marketing. You will oversee signal detection, evaluation, and documentation, contributing to benefit-risk assessments and safety data interpretation across programs.

You will collaborate with cross-functional teams, prepare DSUR/PSUR/RMP documents, and present findings to SMT.