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Reporting to: Vice President, Clinical Development

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety, regulatory compliance, and the meeting of Company objectives. They will ensure the monitoring and communication of the safety of the Company products to both internal and external stakeholders throughout the clinical development to market life cycle. This will be achieved using cost-effective, up to date, globally compliant processes.

This is a unique opportunity to join an agile and progressive team who are working to bring innovative therapies to patients.

RESPONSIBILITIES

+ 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

Requirements

Experience

+ 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

Skills & Abilities

+ 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

Education

+ 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.