Global Patient Safety Lead – ICSR & Compliance

Regeneron Pharmaceuticals, Inc; Uxbridge; Hybrid; GBP 120,000 - 150,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in the United Kingdom is seeking an Associate Director to join our pharmacovigilance case operations team 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.

You will manage timely ICSR receipt, processing and submission across global programmes, uphold quality standards, mentor staff and drive audit readiness with proactive CAPAs.

Qualifications

• Pharmacy, nursing or equivalent qualification.
• Pharmaceutical/biotechnology 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 successful 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 development and commercial programmes.
• Own ICSR quality standards, narrative quality, validity, assessment completeness and source reconciliation.
• Tailor tiered reviews and sampling to complexity, risk and lifecycle stage.
• Optimise AI-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.

Skills

ICSR processing

Pharmacovigilance

Vendor management

Quality assurance

Cross-functional collaboration

Education

Pharmacy or nursing or equivalent qualification

Advanced degree preferred

Job description

Regeneron Pharmaceuticals, Inc in the United Kingdom is seeking an Associate Director to join our pharmacovigilance case operations team 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.

You will manage timely ICSR receipt, processing and submission across global programmes, uphold quality standards, mentor staff and drive audit readiness with proactive CAPAs.