Global Patient Safety Lead: ICSR & QA Ops

Regeneron Pharmaceuticals, Inc.; Uxbridge; Híbrido; GBP 110 000 - 160 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Formação académica

Pharmacy, nursing or equivalent qualification

Descrição da oferta de emprego

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.