Senior Global Patient Safety Lead

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager of Global Patient Safety to lead safety strategies for molecules in development and post-marketing. The role focuses on safety data aggregation, interpretation, and benefit-risk assessment across therapeutic areas.

The position involves signal detection and evaluation, preparation of safety documents (DSUR, PSUR, RMP), presenting at SMT meetings, and cross-functional collaboration with RSOC and IDMC teams.

Qualifications

• Master’s, PhD, or PharmD required.
• 7+ years of risk management experience in the pharmaceutical/biotech industry or health authority.

Responsibilities

• Lead signal detection and evaluation activities per safety plan.
• Prepare DSUR, PSUR, and RMP and respond to health authority queries.
• Present at Signal Management Team meetings and participate in clinical study teams.
• Represent GPS on cross-functional teams (RSOC, IDMC) and other external teams.
• Drive process improvements; develop SOPs and supporting documents.

Skills

Regulatory guidelines

Safety database

Proactive mindset

Communication skills

Education

Master’s/PhD/PharmD

Job description

Regeneron Pharmaceuticals is seeking a Senior Manager of Global Patient Safety to lead safety strategies for molecules in development and post-marketing. The role focuses on safety data aggregation, interpretation, and benefit-risk assessment across therapeutic areas.

The position involves signal detection and evaluation, preparation of safety documents (DSUR, PSUR, RMP), presenting at SMT meetings, and cross-functional collaboration with RSOC and IDMC teams.