Head of Pharmacovigilance
Orchard TherapeuticsLondon, England, United Kingdom • Boston, Massachusetts, United States
Posted October 20, 2025
Full Time
About the Company
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on ending the devastation caused by genetic and other severe diseases by discovering, developing, and commercializing new treatments that tap into the curative potential of hematopoietic stem cell (HSC) gene therapy. In this approach, a patient’s own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease with a single treatment. Founded in 2015, Orchard’s roots go back to some of the first research and clinical developments involving HSC gene therapy. Our team has played a central role in the evolution of this technology from a promising scientific idea to a potentially life-transforming reality. Today, Orchard is advancing a pipeline of HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist. For more information, please visit https://www.orchard-tx.com/.
Job Description
Orchard Therapeutics is seeking a Head of Pharmacovigilance to lead patient safety, regulatory compliance, and product development. The role involves managing product safety across the development, post-market, and clinical phases, ensuring adherence to regulatory requirements, and driving company objectives. The company is a global biotechnology gene therapy company focused on transforming the lives of patients through innovative cell and gene therapies.
Requirements
- Extensive experience in pharmacovigilance leadership in biotech/pharma and/or regulatory agencies
- Extensive knowledge of Pharmacigilance 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
- Education: Medical degree desired, ideally with a relevant post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD).
