Senior Director, Safety Operations

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. 
 
Patient Safety department ensures the safety of patients treated with uniQure products and guarantees uniQure meets all regulatory obligations with regards to pharmacovigilance (PV) requirements.  The Senior Director Safety Operations is a key role in Patient Safety department, responsible for implementing the PV system, providing strategic direction and oversight of PV operations ensuring compliance with global PV regulations. This position represents the Patient Safety department internally and externally at a global level. He/She supports all PV operations including but not limited to vendor selection process, vendor management, inspection readiness, KPIs and CAPAs related to PV operations, case processing and periodic reporting metrics, SOP development and revision, and internal processes that support cross-functional PV initiatives.
 
Key result areas (major duties, accountabilities and responsibilities)   

• Design and implement fit-for-purpose post-marketing PV system at uniQure; oversight and maintenance of PV system validation; continuous optimization of the PV system, enabling efficiency increase through process innovation, automation and other technologies.
• Lead effective vendor management strategies for PV, including budget oversight. Responsible for PV functional service provider strategy and managing the selection process. Responsible for developing a PV database strategy.
• Serves as key point of contact between PV and the CROs regarding PV operation management. Communicates regularly with CROs and oversees ICSR case processing, periodic reporting (DSUR/PSUR) development, signal detection (including literature review) and other delegated tasks.
• Accountable for the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs).
• Provide PV Operational support to clinical trial study and commercial teams.
• Accountable for risk management plan (RMP/REMS) strategy and implementation for uniQure products (both in development and marketed).
• Support the EU QPPV. Oversee PSMF development/updates, implement relevant PV wording in uniQure contracts.
• Ensure uniQure is inspection ready. In partnership with Quality, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
• Serve as a subject matter expert for internal audits and global regulatory inspections.
• Develops PV training plans and competency assessments for Patient Safety department.
• Responsible for Business Continuity management and oversight of the PV System, participate in BCP testing and assume BCP designated role as per crisis scenarios. 
• Implements new pharmacovigilance legislation into PV system, metrics, technical requirements & training.
• Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant uniQure stakeholders, including Clinical Development, Clinical Operations, Commercial, Medical Affairs, Quality, Biostatistics, IT, Legal, and Affiliates to establish and maintain an effective PV system.
• Provides oversight and direction to direct report(s).

 
Qualifications & Skills

• Bachelors degree in scientific related field preferred or combination education/experience.
• 10+ years of PV experience in the pharmaceutical industry with significant experience in biotech.
• Clinical trial product support and commercial product support experience preferred.
• Proven track record of leadership and operational excellence.
• Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
• Able to work independently, establish work priorities, and execute decisions with minimal guidance.
• Able to influence across stakeholders and manage within a cross-functional matrix; seen as a collaborative partner within the organization.
• Experienced in health authority inspections and/or internal or third-party audits.
• Excellent knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of related quality assurance systems.
• Experienced in developing training & quality documents (SOP / Guidelines / CAPAs).

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