Associate Director Global Patient Safety

About the Role

Join our Global Patient Safety team at Regeneron, a science-driven organization developing life-changing medicines for serious diseases. In this hybrid 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.

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 organizational projects through individual contributors or other managers.
• Strong communication and partner management skills, with ability to resolve and escalate complex issues.

Location

This is an onsite position based in one of our US locations or in Uxbridge, UK (hybrid).

Benefits

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
• Family support benefits

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, details will be provided during the recruitment process.

Pay

Salary Range (annually): $157,200.00 - $256,600.00 (for jobs in Canada). The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may influence certain elements of pay or benefits.