Head of Safety
uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
The Head of Medical Safety and Pharmacovigilance is accountable for defining the overall Patient Safety strategy and manage the pharmacovigilance requirements for uniQure. They will take responsibility for defining the risk/benefit profile of all of uniQure clinical programs and are entrusted to ensure the safety of patients is safeguarded; that all risk minimization measures are adequately developed and implemented.
The Head of Medical Safety and Pharmacovigilance reports to the Chief Medical Officer (CMO) and is a valued member of the CMO Leadership team. They will be responsible for the Director of Clinical Safety.
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 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 definition, monitoring and evaluation through translation safety activities in collaboration with preclinical safety and clinical development
- Ensure robust signal management process including the execution 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 reviewed and managed on an ongoing
- 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
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- 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 including safety leadership experience
- Thorough understanding and expertise of pharmacovigilance 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
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