Global Patient Safety Associate Director – Hybrid

Regeneron Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead pharmacovigilance case operations in a hybrid setting. You will oversee ICSR processing quality, lifecycle readiness, and cross-functional collaboration with vendors and partners worldwide.

The role emphasizes establishing KPI frameworks, managing audits and inspections, and driving corrective actions while mentoring staff and sustaining regulatory timelines. Hybrid working model offered with global impact.

Qualifications

• Pharmacovigilance experience in drug safety and quality oversight.
• Experience supervising teams on complex projects and cross-functional collaboration.
• Understanding of regulatory pharmacovigilance requirements (FDA, EU, ICH).

Responsibilities

• Oversee timely ICSR receipt, processing, distribution and submission across global programmes.
• Own ICSR quality standards, narrative quality, validity and source reconciliation.
• Lead audits, inspections and corrective actions, ensuring timely responses.
• Establish KPI frameworks, vendor governance and capacity planning.
• Mentor staff and ensure regulatory timelines and SOP adherence.

Skills

Pharmacovigilance

ICSR processing

Vendor governance

Audits & inspections

Education

Pharmacy degree

Regulatory knowledge

Tools

Case management systems

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead pharmacovigilance case operations in a hybrid setting. You will oversee ICSR processing quality, lifecycle readiness, and cross-functional collaboration with vendors and partners worldwide.

The role emphasizes establishing KPI frameworks, managing audits and inspections, and driving corrective actions while mentoring staff and sustaining regulatory timelines. Hybrid working model offered with global impact.