Associate Director Global Patient Safety
About The Position
Regeneron is seeking an Associate Director to join its pharmacovigilance case operations team and support global portfolios in a hybrid setting. The role oversees case-processing quality and operational readiness while collaborating with vendors and internal and external partners. It supports global development and commercial programmes and contributes to a science-driven organization focused on developing medicines for serious diseases. The Associate Director oversees the receipt, processing, distribution and submission of individual case safety reports (ICSRs), and maintains vendor resourcing, training, volume readiness and structured feedback. The role owns ICSR quality standards and quality-related operations, optimizes AI-enabled data ingestion and workflows, supports audits and health authority inspections, and leads root cause analysis and corrective and preventive actions. It also establishes performance frameworks, governs vendor service levels, maintains regulatory and partner timelines and procedures, mentors assigned staff, and escalates delivery risks.
Requirements
- Pharmacy, nursing or equivalent qualification.
- Typically 10 years of pharmaceutical or biotechnology pharmacovigilance, drug safety or pharmacovigilance quality experience.
- Knowledge of FDA, EU and ICH pharmacovigilance requirements across clinical trials and post-marketing.
- Experience supervising teams on complex projects and collaborating successfully across functions.
- Ability to organize 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.
- Optimize AI-enabled data ingestion, quality workflows and metric generation.
- Support audits and health authority inspections, maintain inspection readiness, and coordinate 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 utilization, 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Associate degree
