Global Patient Safety Lead ICSR & Quality

Regeneron Pharmaceuticals; Dublin; Hybrid; EUR 102,000 - 165,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking an Associate Director to join the pharmacovigilance case operations team in a hybrid setting. You will oversee ICSR receipt, processing, and submission across global development and commercial programmes, while maintaining quality standards and coordinating with vendors and partners.

The role requires a pharmacy or nursing qualification (advanced degree preferred) and extensive pharmacovigilance experience, with leadership of cross-functional teams and strong

Qualifications

• Pharmacovigilance, drug safety or pharmacovigilance quality experience is required.
• Experience supervising teams on complex projects and cross-functional collaboration is required.
• Regulatory knowledge across FDA, EU and ICH pharmacovigilance requirements is required.

Responsibilities

• Oversee ICSR receipt, processing, distribution and submission across global development and commercial programmes.
• Own ICSR quality standards, narrative quality, validity and assessment completeness.
• Lead audits/inspections readiness and lead root cause analysis with remediation.
• Establish KPI frameworks for volumes, cycle times, resource utilisation and vendor performance.
• Mentor staff and manage workload, escalation and delivery risks.

Education

Pharmacy, nursing or equivalent qualification

Advanced degree preferred

Job description

Regeneron Pharmaceuticals is seeking an Associate Director to join the pharmacovigilance case operations team in a hybrid setting. You will oversee ICSR receipt, processing, and submission across global development and commercial programmes, while maintaining quality standards and coordinating with vendors and partners.

The role requires a pharmacy or nursing qualification (advanced degree preferred) and extensive pharmacovigilance experience, with leadership of cross-functional teams and strong