Associate Director Global Patient Safety

Regeneron Pharmaceuticals

1d•Hybrid

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, PV Case Operations to 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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 escalate complex issues.

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.