Associate Director Global Patient Safety

Regeneron Pharmaceuticals • Warren, MI

1d • Hybrid

About The Position

Regeneron is seeking an Associate Director to join its pharmacovigilance case operations team, supporting global portfolios in a hybrid setting. The role oversees individual case safety report (ICSR) processing quality and operational readiness across global development and commercial programmes, collaborating with vendors and internal and external partners. The position contributes to a science-driven organization developing medicines for serious diseases.

The Associate Director is responsible for ICSR receipt, processing, distribution and submission; vendor readiness and governance; quality standards and review approaches; artificial intelligence-enabled workflows; inspection readiness; root cause analysis and remediation; corrective and preventive actions; performance metrics; and regulatory and partner timelines. The role also mentors assigned staff, balances workloads and escalates delivery risks appropriately. Multiple locations are being considered. The role is hybrid, with on-site expectations to be discussed with the recruiter and hiring manager.

Requirements

• Pharmacy, nursing or equivalent qualification.
• Pharmaceutical or biotechnology pharmacovigilance, drug safety or pharmacovigilance quality experience, typically 10 years.
• Knowledge of Food and Drug Administration, European Union and International Council for Harmonisation pharmacovigilance requirements across clinical trials and post-marketing.
• Experience supervising teams on complex projects.
• Successful cross-functional collaboration.
• Ability to organise projects and manage goals through individual contributors or managers, supporting colleagues as needed.

Nice To Haves

• Advanced degree.

Responsibilities

• Oversee timely ICSR receipt, processing, distribution and submission across global development and commercial programmes.
• Maintain vendor resourcing, training, volume readiness and structured feedback.
• Own ICSR quality standards, including narrative quality, validity, assessment completeness and source reconciliation.
• Tailor tiered reviews and sampling to case complexity, risk and lifecycle stage.
• Optimise artificial intelligence-enabled data ingestion, quality workflows and metric generation.
• Support audits and health authority inspections, maintaining inspection readiness and coordinating responses to findings.
• Lead documented, actionable root cause analysis and targeted remediation for recurring errors, deviations and compliance failures.
• Own corrective and preventive actions through closure, including post-implementation effectiveness checks and timely commitments.
• Escalate delivery risks.
• Establish key performance indicator frameworks covering volumes, cycle times, resource utilisation, overtime and vendor benchmarks.
• Conduct vendor governance against contractual service-level agreements.
• Maintain regulatory, licence-partner and third-party submission timelines, standard operating procedures and working instructions.
• Mentor assigned staff and communicate deliverables, interests and issues promptly to management and partners.
• Balance workloads, compliance and quality through practical issue resolution and appropriate escalation.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Director