Senior PV Case Operations Leader – Quality & Audit-Ready

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks an Associate Director to lead the PV Case Operations team. You will oversee pharmacovigilance operations, ensure ICSR quality and CAPA delivery, and manage vendor and case processing deliverables across global development programs and marketed products.

The role emphasizes inspection readiness and KPI governance to support regulatory commitments. Qualified candidates have at least a Bachelor's degree with 10 years in PV/Drug Safety,

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 10+ years in Pharmacovigilance/Drug Safety/PV Quality experience.
• Strong knowledge of FDA, EU and ICH guidelines governing PV activities.
• Experience managing and supervising teams on complex projects.
• Contributes to and manages organizational projects and goals.
• Mentors staff and supports cross-functional collaboration.

Responsibilities

• Oversee ICSR quality review processes, including narrative quality, case validity, source document reconciliation.
• Establish tiered quality review frameworks and sampling strategies by case complexity and lifecycle stage.
• Drive continuous improvement in ICSR quality by identifying trends and root causes of errors.
• Support interactions with auditors and Health Authority inspectors.
• Lead root cause analysis for quality deviations and compliance failures.

Skills

Pharmacovigilance

Team leadership

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron Pharmaceuticals, Inc. in the United States seeks an Associate Director to lead the PV Case Operations team. You will oversee pharmacovigilance operations, ensure ICSR quality and CAPA delivery, and manage vendor and case processing deliverables across global development programs and marketed products.

The role emphasizes inspection readiness and KPI governance to support regulatory commitments. Qualified candidates have at least a Bachelor's degree with 10 years in PV/Drug Safety,