Global Pharmacovigilance Director (Hybrid)

Regeneron Pharmaceuticals; Tarrytown (GA); Hybride; USD 176 000 - 287 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals seeks an Associate Director to join its pharmacovigilance case operations team in a hybrid setting across multiple U.S. sites. You will oversee ICSR processing quality, drive continuous improvement with vendors and partners, and ensure regulatory readiness for global programs.

You will mentor staff, manage KPIs, and escalate risks while enabling cross-functional collaboration to deliver high-quality safety data for development and commercial portfolios.

Qualifications

• Pharmacovigilance and drug safety experience with quality oversight.
• Experience leading cross-functional teams and audits.
• Vendor management and performance monitoring.
• Regulatory knowledge across global standards (FDA/EU/ICH).

Responsabilités

• Oversee timely ICSR receipt, processing, distribution and submission across global programs.
• Own ICSR quality standards, narrative quality and source reconciliation.
• Lead audits and health authority inspection readiness; drive CAPAs.
• Establish KPI frameworks for volumes, cycle times and vendor performance.
• Mentor staff and communicate deliverables to management.

Connaissances

Pharmacovigilance

Quality management

Vendor management

Cross-functional work

Formation

Pharmacy qualification

Advanced degree preferred

Description du poste

Regeneron Pharmaceuticals seeks an Associate Director to join its pharmacovigilance case operations team in a hybrid setting across multiple U.S. sites. You will oversee ICSR processing quality, drive continuous improvement with vendors and partners, and ensure regulatory readiness for global programs.

You will mentor staff, manage KPIs, and escalate risks while enabling cross-functional collaboration to deliver high-quality safety data for development and commercial portfolios.