Senior PV Case Operations Lead — Quality & Compliance

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

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead PV Case Operations, overseeing case processing, ICSR quality reviews, CAPAs, and audits.

The role ensures regulatory compliance across global development programs and marketed products, with a focus on metrics, vendor performance, and timely submissions. Work location is on-site in Warren, NJ (4 days/week) with up to 25% travel; the incumbent mentors staff, partners with auditors, and drives process improvements to support

Qualifications

• Minimum Bachelor's Degree; Advanced Degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/ PV Quality experience.
• Experience managing and supervising teams on complex projects.

Responsibilities

• Oversee PV case processing deliverables across global development programs and marketed products.
• Lead ICSR quality review processes, including narrative quality and source document reconciliation.
• Establish tiered quality review frameworks and sampling strategies by risk and lifecycle stage.
• Drive continuous improvement in ICSR quality; identify trends and implement remediation.
• Interact with auditors and Health Authority inspectors; respond to findings.
• Develop and track CAPAs; ensure timely closure and effectiveness checks.
• Monitor KPIs; manage vendor performance frameworks and governance meetings.
• Ensure compliance with regulations, guidelines, and Regeneron SOPs.

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead PV Case Operations, overseeing case processing, ICSR quality reviews, CAPAs, and audits.

The role ensures regulatory compliance across global development programs and marketed products, with a focus on metrics, vendor performance, and timely submissions. Work location is on-site in Warren, NJ (4 days/week) with up to 25% travel; the incumbent mentors staff, partners with auditors, and drives process improvements to support