At a Glance
- Tasks: Lead case processing and vendor oversight in a dynamic global team.
- Company: Join Regeneron, a science-driven company making a real difference in patient lives.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team committed to equal opportunity and inclusion.
- Why this job: Make an impact in global patient safety while working with innovative technologies.
- Qualifications: 10 years of experience in Pharmacovigilance and strong leadership skills required.
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, PV Case Operations to join our Global Patient Safety team, supporting case processing across global development and commercial programmes in a hybrid work mode. In this 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
This is an onsite position to be based in one of our US locations or in Uxbridge, UK (hybrid).
Discover your role:
- 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.
This role requires:
- 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 escalation complex issues.
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 Traveller 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.
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Associate Director, Global Patient Safety in Uxbridge employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
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We think this is how you could land Associate Director, Global Patient Safety in Uxbridge
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We think you need these skills to ace Associate Director, Global Patient Safety in Uxbridge
Some tips for your application 🫡
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