Global Head of Patient Safety & Pharmacovigilance

uniQure; Basel; On-site; CHF 180,000 - 300,000; Full time

Job summary

uniQure seeks a Head of Patient Safety to define the global pharmacovigilance strategy and oversee safety requirements for clinical programs. You will supervise PV processes, risk management and regulatory submissions across markets, reporting to the CMO and guiding safety scientists.

Based in Basel, Amsterdam or Lexington, the role requires a decade of medical safety leadership, regulatory expertise and strong collaboration across clinical development, regulatory affairs and quality teams.

Qualifications

• MD or PharmD required with medical safety/clinical research experience.
• 10+ years in biotechnology/pharma with leadership in safety.
• Strong understanding of FDA/EMA, GCP and ICH guidelines.

Responsibilities

• Lead global safety and pharmacovigilance strategy for the portfolio.
• Oversee regulatory safety submissions (INDs/NDAs/MAAs).
• Collaborate cross-functionally with Clinical Dev, Regulatory, Medical Affairs, and Quality.
• Ensure high-quality safety data, signal detection and risk minimization systems.
• Own risk-benefit/reassessment and manage PBRER/PSUR activities.

Skills

Safety leadership

Regulatory knowledge

Leadership

Strategic thinking

Communication

Gene therapy knowledge

Education

MD or PharmD

Job description

uniQure seeks a Head of Patient Safety to define the global pharmacovigilance strategy and oversee safety requirements for clinical programs. You will supervise PV processes, risk management and regulatory submissions across markets, reporting to the CMO and guiding safety scientists.

Based in Basel, Amsterdam or Lexington, the role requires a decade of medical safety leadership, regulatory expertise and strong collaboration across clinical development, regulatory affairs and quality teams.