Associate Director, PV Case Operations
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. The Associate Director, PV Case Operations will join our Global Patient Safety team, supporting case processing across global development and commercial programmes in a hybrid work mode. In this role, you will lead vendor oversight, Individual Case Safety Report (ICSR) quality governance, and inspection readiness while collaborating with vendor teams, internal partners, license partners, auditors, and Health Authority inspectors.
Location
Uxbridge, UK (hybrid)
Responsibilities
- Own accurate, timely case processing across global development and marketed products, per applicable regulations and Regeneron SOPs.
- Lead vendor oversight for end‑to‑end ICSR receipt, processing, distribution, and submission.
- Own ICSR quality standards covering narrative, case validity, and source document reconciliation.
- Establish tiered quality review frameworks aligned to case complexity, risk, and product lifecycle stage.
- Monitor submission timelines and vendor SLAs, maintain inspection readiness, and respond to audit findings.
- Lead root cause analysis and own CAPAs through closure and effectiveness checks.
- Evaluate AI‑enabled tools for data ingestion, workflow automation, and metrics.
- Mentor staff and communicate clearly with senior management and partners.
Requirements
- Pharmacy, nursing, or equivalent degree required; advanced degree preferred.
- Typically 10 years of Pharmacovigilance, Drug Safety, or PV Quality experience in pharma or biotech.
- Well‑informed on FDA, EU, and ICH guidelines governing pharmacovigilance for clinical trial and post‑marketing environments.
- Experience managing teams on complex, cross‑functional projects.
- Proven ability to deliver organisational projects through individual contributors or other managers.
- Strong communication and partner management skills, with ability to resolve and escalade complex issues.
Benefits & Compensation
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit the Regeneron website. For other locations, additional information will be provided during the recruitment process.
Equal Opportunity Statement
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
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