Senior Global Patient Safety Leader — Signals & Risk

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); Presencial; USD 151.000 - 246.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager for Global Patient Safety to drive safety strategies for clinical and post‑marketing programs. You will lead signal detection, evaluation and the preparation of DSUR/PSUR/RMP documents while coordinating with RSOC and IDMC teams.

The role emphasizes data aggregation, safety interpretation, benefit‑risk assessment and proactive process improvements in a fast‑growing, science‑driven environment.

Formación

• Minimum a Master's, PhD, or PharmD.
• 7+ years of relevant risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH guidelines for pharmacovigilance in trials and post‑marketing.
• Ability to work with a safety system database for medical case review and queries.
• Proactive, self‑disciplined with ability to meet deliverables and prioritize.
• Effective verbal and written safety communication.

Responsabilidades

• Complete signal detection activities per the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and responses.
• Prepare and deliver SMT presentations; join study teams for compounds.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross‑functional teams (RSOC, IDMC, etc.).
• Contribute to SOPs, WIs and related process improvements.

Conocimientos

Signal detection

Safety signal evaluation

Safety documentation

Presentation skills

Cross-functional collaboration

Process improvement

Educación

Master's/PhD/PharmD

Descripción del empleo

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager for Global Patient Safety to drive safety strategies for clinical and post‑marketing programs. You will lead signal detection, evaluation and the preparation of DSUR/PSUR/RMP documents while coordinating with RSOC and IDMC teams.

The role emphasizes data aggregation, safety interpretation, benefit‑risk assessment and proactive process improvements in a fast‑growing, science‑driven environment.