Senior Director, Pharmacovigilance & Safety Operations

uniQure; Amsterdam; On-site; EUR 150,000 - 190,000; Full time

Job summary

uniQure is seeking a Senior Director of Safety Operations to lead the pharmacovigilance (PV) function globally. You will design, implement and optimize the PV system, ensure regulatory compliance and drive cross‑functional collaboration with Clinical Development, Operations, Medical Affairs, Quality and IT to support life‑changing therapies.

The role requires a science degree and 10+ years in PV with leadership experience, including audits and inspections.

Qualifications

• Bachelor's degree in a scientific field; combination education/experience acceptable.
• 10+ years of PV experience in pharma/biotech with leadership.
• Clinical trial product support and commercial product support experience preferred.
• Proven leadership and operational excellence track record.
• Ability to shape department goals, drive efficiencies, and develop best practices.

Responsibilities

• Design and implement post-marketing PV system; oversee PV system validation and optimization.
• Lead vendor management strategies for PV; oversee CRO relationships and PV database strategy.
• Coordinate ICSR case processing, DSUR/PSUR development, signal detection and CAPA actions.
• Develop and maintain Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs).
• Provide PV operational support to clinical and commercial teams; ensure inspection readiness.

Skills

PV leadership

Regulatory knowledge

Vendor management

Cross-functional collaboration

Audits & inspections

Education

Bachelor's degree in science

Job description

uniQure is seeking a Senior Director of Safety Operations to lead the pharmacovigilance (PV) function globally. You will design, implement and optimize the PV system, ensure regulatory compliance and drive cross‑functional collaboration with Clinical Development, Operations, Medical Affairs, Quality and IT to support life‑changing therapies.

The role requires a science degree and 10+ years in PV with leadership experience, including audits and inspections.