Head of Pharmacovigilance
- Leads the development and execution of a strategic, globally aligned approach to product safety across development and post-marketing, including but not limited to:
- Bringing expertise through the writing of clinical development plans, protocols, and study reports, aggregate analyses (PBRERs / DSURs), regulatory submissions (BLA/NDA/MAA dossiers, briefing documents, Risk Management Plans, REMS), and post-marketing commitments.
- Creating detailed reports and evaluations of benefit-risk for internal audiences and external regulatory stakeholders.
- Driving proactive, continuous risk assessment to optimize the benefit-risk profile of all products in the development pipeline and on the market.
- Ensures the implementation and governance of a compliant Pharmacovigilance system consistent with industry best practices that:
- Enabling real-time monitoring and benefit-risk assessment throughout the product lifecycle including post-marketing surveillance and post-approval commitments,
- Meeting global regulatory requirements, and advances Company strategic objectives while safeguarding patient safety,
- Ensuring high-quality Standard Operating Procedures are described within a robust Pharmacovigilance System Master File.
- Provides strong leadership to cultivate a high-performance, results-driven, inspection ready culture within the Pharmacovigilance department. Actively coaches and mentors staff to support career growth, while building and sustaining a high-performing global team. Ensures all team members are accountable for delivering activities in a timely, accurate, and high-quality manner through leadership by example.
- Ensures a high profile for the Pharmacovigilance department through regular collaboration and alignment with other senior management including other functional leads.
- Takes an active and effective role on Company Committees governing safety activities
- Effectively leads the Pharmacovigilance Department during the conduct of regulatory agency inspections and internal audits in close collaboration with GVP QA.
- Plans Pharmacovigilance resources and activities to support clinical programs including creation and management of departmental budget and oversight and management vendors
- Extensive experience in pharmacovigilance leadership roles in biotech/pharma and/or regulatory agencies
- Extensive knowledge of Pharmacovigilance best practices and international regulatory requirements (EMA, MHRA, FDA and, ideally, PMDA), including relevant GCP/ICH guidelines
- Proven experience interacting with Regulatory Authorities for IND, NDA, BLA, and MAA submissions
- Experienced in the implementation of commercial drug safety databases and managing software supporting global Pharmacovigilance operations
- Gene therapy/ultra rare/orphan diseases background strongly desired
- Demonstrated ability to develop and implement global PV strategy and maintain a compliant, inspection-ready system
- Skilled in working within matrixed, global organizations and successfully collaborating with international cross-functional teams
- Proven leadership in pharmacovigilance with ability to build high performing PV teams and drive change in dynamic, cross-cultural environments
- Strong strategic and operational acumen, able to lead teams while contributing hands-on
- Exceptional communication and influencing skills, including confident engagement with regulatory authorities and key stakeholders
- Decisive, accountable, and proactive problem-solver with strong analytical and organizational skills
- Collaborative and solution-oriented mindset with a track record of delivering in fast-paced, complex settings
- Medical degree desired, ideally with a relevant post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD). Experienced candidates with an advanced degree (e.g, PharmD., Ph.D.) will also be considered.
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