Senior Director, Global Patient Safety – Oncology

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Híbrido; USD 205.000 - 342.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Director of Global Patient Safety to lead safety strategy for assigned compounds and act as GPS representative on strategic teams. The role requires extensive PV experience and collaboration across internal and external partners.

You will guide safety surveillance, signal management, and regulatory communications (DSURs/PSURs), mentor engineers, and contribute to SOPs. Hybrid work with on-site requirements is expected in multiple locations.

Formación

• Minimum 10+ years total experience in PV or related medical field.
• 5+ years PV experience with PharmD/PhD/MD.
• Oncology experience is a plus.

Responsabilidades

• Lead safety strategy for Global Patient Safety (GPS) for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC, SPT) and collaborate with external partners.
• Develop and maintain safety documents (DSURs, PSURs, development RMPs).
• Mentor junior safety scientists and contribute to SOPs and best practices.

Conocimientos

Pharmacovigilance

Safety strategy

Regulatory compliance

Educación

PharmD / PhD / MD

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks a Director of Global Patient Safety to lead safety strategy for assigned compounds and act as GPS representative on strategic teams. The role requires extensive PV experience and collaboration across internal and external partners.

You will guide safety surveillance, signal management, and regulatory communications (DSURs/PSURs), mentor engineers, and contribute to SOPs. Hybrid work with on-site requirements is expected in multiple locations.