Associate Director Global Patient Safety

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 110,000 - 160,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead pharmacovigilance case operations in a hybrid role. You will oversee ICSR processing quality, vendor management, and readiness across global portfolios, partnering with internal and external teams.

The role requires a pharmacy/nursing or equivalent qualification, ~10 years in pharmacovigilance, and strong leadership in cross-functional environments. Advanced degree preferred; regulatory knowledge across FDA, EU, ICH is essential.

Qualifications

• Pharmacy, nursing or equivalent qualification.
• Pharmacovigilance, drug safety or pharmacovigilance quality experience, typically 10 years.
• Knowledge of FDA, EU and ICH pharmacovigilance requirements across clinical trials and post-marketing.
• Experience supervising teams on complex projects and cross-functional collaboration.
• Organisational project and goal management through individual contributors or managers.
• Advanced degree preferred.

Responsibilities

• Oversee timely ICSR receipt, processing, distribution and submission across global programmes; maintain vendor resourcing, training, volume readiness and feedback.
• Own ICSR quality standards, narrative quality, validity and source reconciliation; tailor reviews to complexity, risk and lifecycle stage.
• Optimise AI-enabled data ingestion, quality workflows and metric generation.
• Support audits and inspections; maintain readiness and coordinate findings; lead root cause analysis and remediation.
• Own corrective and preventive actions through closure and timely commitments; escalate delivery risks.
• Establish KPI frameworks covering volumes, cycle times, resource utilisation, overtime and vendor benchmarks; governance against SLAs.
• Maintain regulatory, licence-partner and third-party submission timelines, SOPs and working instructions; mentor staff and communicate deliverables.
• Balance workloads, compliance and quality through issue resolution and escalation.

Education

Pharmacy, nursing or equivalent qualification

Job description

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.,

• 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.
  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-marking.
• 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

If you have any questions, please speak with your recruiter.