Vice President, Safety

uniQure; Basel; Vor Ort; CHF 180.000 - 300.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Safety leadership

Regulatory knowledge

Leadership

Strategic thinking

Communication

Gene therapy knowledge

Ausbildung

MD or PharmD

Jobbeschreibung

Place in the Organization

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

The Head of Patient Safety is accountable for defining the overall Patient Safety strategy and managing the pharmacovigilance requirements for uniQure. They take responsibility for defining the risk/benefit profile of all uniQure clinical programs and are entrusted to ensure the safety of patients is safeguarded, and that all risk minimization measures are adequately developed and implemented.

The Head of Patient Safety reports to the Chief Medical Officer (CMO) and is a valued member of the CMO Leadership team. They are responsible for a team of safety scientists and pharmacovigilance (PV) process experts.

This role can be based in any of the following uniQure offices: Amsterdam, Basel or Lexington.

Key Result Areas (major Duties, Accountabilities And Responsibilities)

• Lead the global safety and pharmacovigilance strategy across the uniQure portfolio
• Accountability for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.)
• Establish and maintain effective cross-functional collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Medical Affairs, Commercial, Quality and Program Leadership teams to develop strategies to identify, evaluate and validate safety concerns
• Ensure systems are in place for accurate monitoring of the safety
  • Identify appropriate safety vendors and services to enable safety monitoring for all uniQure programs
  • Ensure efficient management and oversight of safety vendors
  • Ensure the existence and operation of a high quality and cost effective support systems for pharmacovigilance (information databases, signal detection systems etc.)
  • Guarantee accuracy, completeness and quality of safety data collected and reported
• Be responsible for up-to-date safety risk profile and risk minimization for each uniQure program
  • Ensure appropriate process for potential risk identification, monitoring and evaluation through translation safety activities in collaboration with preclinical safety and clinical development
  • Ensure robust signal management process including the implementation of risk minimization measures
  • Ensure that an action plan is developed in case a new safety signal is detected
  • Develop a process for safety risks to be reviewed and managed on an ongoing basis
• Develop a process for providing regular safety and pharmacovigilance reports to meet regulatory obligations and timelines
• Be a driver to create a Patient Safety culture at uniQure
• Own the benefit-risk reassessment and risk management planning (RMP/REMS) for uniQure products across their full commercial lifecycle, including real-world effectiveness of risk minimization measures and safety-driven label changes
• Accountable for periodic safety reporting (PBRER/PSUR) and health authority interactions arising from post-marketing safety findings across all markets where uniQure products are commercialized
• Oversee long-term follow-up programs and patient registries to monitor for delayed-onset safety events, consistent with regulatory expectations for gene therapy products
• Expand real-world safety monitoring and signal detection (spontaneous reports, literature, registries, patient support programs) to match uniQure's growing commercial footprint
• Drive safety-driven recalls, market withdrawals and emergency risk communications, escalating material issues to the CMO and appropriate governance committees
• Ensure appointment, resourcing and oversight of the Qualified Person for Pharmacovigilance (QPPV), or hold the QPPV role directly, to meet the EU pharmacovigilance legal obligations
• Build, implement and maintain uniQure's global fit-for-purpose Pharmacovigilance System, including the Pharmacovigilance System Master File (PSMF), ensuring compliance with GVP and applicable regulations across all markets

Qualifications & Skills

• MD or equivalent degree or PharmD required
• A minimum of 10 years of relevant medical safety and clinical research experience in the biotechnology or pharmaceutical industry, including safety leadership experience
• Thorough understanding and expertise of pharmacovigilance regulations: FDA and EMA regulations, GCP & ICH guidelines
• Experience in gene therapy and/or neurosciences is advantageous
• Demonstrated leadership, influencing and communication abilities that are essential to effectively engage wider stakeholders, and who can also guide the collaborative efforts of scientists across functions that need to play a part in progressing the safety strategy and delivering the various safety/PV requirements
• Strategic thinking & strong analytical ability - able to apply critical and holistic thinking in terms of safety for 'overall value add' to deliver effective impact for cross-functional teams

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws.

If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].