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

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

Associate Director – Global Patient Safety

Key skills