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About the Role
Oversee case processing quality and operational readiness while collaborating with vendors and internal and external partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Oversee timely individual case safety report (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, narrative quality, validity, assessment completeness and source reconciliation.
- Tailor tiered reviews and sampling to 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 findings responses.
- Lead documented, actionable root cause analysis and targeted remediation for recurring errors, deviations and compliance failures.
- Own corrective and preventive actions through closure, 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.
Requirements
- Pharmacy, nursing or equivalent qualification.
- Pharmaceutical/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 and successful cross-functional collaboration.
- Organisational project and goal management through individual contributors or managers, supporting colleagues as needed.
- Advanced degree preferred.
Location
- Hybrid
Work Type
- Hybrid
Experience Level
- Associate Director
- 10 years
Education Level
- Pharmacy, nursing or equivalent qualification
- Advanced degree preferred
Benefits
- 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
About the Company
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- 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, and family support benefits.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.