Associate Director Global Patient Safety
- Location
- TARRYTOWN; Warren
- Work mode
- On-site
- Employment type
- Full-time
About the job
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Associate Director to join our pharmacovigilance case operations team, supporting our global portfolios in a hybrid setting. In this role, you will 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.
When & where: Multiple locations are being considered for this role (Hybrid).
Discover your role:
- 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.
- You balance workloads, compliance and quality through practical issue resolution and appropriate escalation.
This role requires:
• Pharmacy, nursing or equivalent qualification.
- 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.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. 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 apply and influence certain elements of pay or 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually) $176,100.00 - $287,300.00
From Regeneron Pharmaceuticals's careers page (Workday), checked 29 Oct 2026.
How to apply
- Select Apply on regeneron.com. It opens Regeneron Pharmaceuticals's own application form in a new tab, run on Workday.
- Fill in the form and upload your résumé there. Jobiwork never sees your application.
- Regeneron Pharmaceuticals will reply to you directly. No real employer asks you for money to apply.
Posted 28 Oct 2026 · checked 29 Oct 2026 · Report this job