Head of Pharmacovigilance

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases. The Head of Pharmacovigilance will lead pharmacovigilance for Orchard, driving patient safety, regulatory compliance, and the achievement of company objectives across the clinical development to market lifecycle.

• Leads the development and execution of a strategic, globally aligned approach to product safety across development and post‑marketing, including but not limited to:
  • Writing clinical development plans, protocols, and study reports; preparing aggregate analyses (PBRERs / DSURs); submitting regulatory dossiers (BLA/NDA/MAA), briefing documents, Risk Management Plans, REMS, and post‑marketing commitments.
  • Creating detailed benefit‑risk reports and evaluations for internal audiences and external regulatory stakeholders.
  • Driving proactive, continuous risk assessment to optimize the benefit‑risk profile of all products in the pipeline and on the market.
• Ensures the implementation and governance of a compliant pharmacovigilance system consistent with industry best practices:
  • Enables real‑time monitoring and benefit‑risk assessment throughout the product lifecycle, including post‑marketing surveillance and post‑approval commitments.
  • Meets global regulatory requirements and advances company strategic objectives while safeguarding patient safety.
  • Maintains high‑quality Standard Operating Procedures 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 and build a global team.
• Ensures a high profile for the pharmacovigilance department through regular collaboration and alignment with senior management and other functional leads.
• Takes an active and effective role on company committees governing safety activities.
• Leads the pharmacovigilance department during 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 a departmental budget and oversight of 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, PMDA) and relevant GCP/ICH guidelines.
• Proven experience interacting with regulatory authorities for IND, NDA, BLA, and MAA submissions.
• Experience in implementing commercial drug safety databases and managing software for global pharmacovigilance operations.
• Gene therapy or ultra‑rare/orphan disease background strongly desired.

• Demonstrated ability to develop and implement a 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 the ability to build high‑performing 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, 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 postgraduate qualification (e.g., MRCP, MRCS, MFPM, MD). Advanced degree holders (Pharm
  
  D, Ph.D.) will also be considered.