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About the Role
The Director, Pharmacovigilance is a safety expert responsible for the safety and benefit-risk profile of assigned products. This role leads global medical product-related activities, collaborates on strategic programs, and interfaces with Health Authorities. The position provides medical and clinical oversight for gene therapy programs, ensuring participant safety, data integrity, and regulatory compliance.
Responsibilities
- Support the Head of PV in the oversight of PV systems, including Veeva safety database.
- Lead and collaborate on strategy, review, and finalization of aggregate safety reports.
- Lead the core risk management strategy, risk assessment, and risk minimization measures.
- Lead the signal management process for post-marketing products and evaluate safety data for investigational products.
- Support the PV scientist in responding to safety questions and serve as a subject matter expert on global safety regulations.
- Review and analyze safety data from post-marketing sources and clinical trials.
- Provide input into global literature monitoring strategy.
- Review and manage the benefit-risk profile for assigned compounds and products.
- Provide input, review, and lead responses to safety questions from regulatory authorities.
- Effectively communicate safety issues to relevant stakeholders, including senior management.
- Act as a medical pharmacovigilance advisor/subject matter expert for clinical programs.
- Collaborate with other teams for assigned investigational programs, including clinical trial activities.
- Provide clinical sponsor oversight and review of SAEs.
- Collaborate with cross-functional team members for assigned investigational programs.
- Conduct ongoing medical data review and provide timely clinical interpretation of emerging data.
- Perform regular reviews of listings, coding, and protocol deviations.
- Review listings, tables, and figures during database lock preparation.
- Perform real-time safety monitoring of trial participants, including medical review of AEs and SAEs.
- Review and provide medical input into clinical study documents, including protocols, amendments, informed consent forms, and investigator brochures.
Requirements
- Minimum 7 years of experience in the pharmaceutical industry or clinical care setting.
- Demonstrated experience in drug safety (minimum 3-5 years).
- Prior direct interactions with EU and ROW regulatory authorities.
- Strong understanding of GCP, ICH guidelines, and pharmacovigilance practices.
- Experience in managing PV scientist(s) overseeing activities for assigned compounds/products.
- Demonstrated success working as a physician in a pharmacovigilance department.
- Sound knowledge of global regulatory requirements (EU, UK, FDA, and ROW).
- Demonstrated experience as a medical monitor in clinical trials (preferably Phase I/II, and/or gene therapy studies).
- Familiarity with neurometabolic diseases.
- Ability to work independently, manage deliverables proactively, and thrive in a dynamic development environment.
- Excellent grammatical, editorial, and proofreading skills.
- Effective organizational and planning skills.
- Ability to understand, interpret, analyze, and clearly present scientific and medical data.
- Ability to develop and maintain relationships with program counterparts in Clinical Development, Regulatory, Clinical Operations, Medical Affairs, and other internal departments.
- Demonstrated ability to lead and collaborate within highly complex organizations and across functions and geographies.
Skills
- Drug safety
- Pharmacovigilance
- GCP
- ICH guidelines
- Regulatory affairs
- Medical monitoring
- Clinical trials
- Gene therapy
- Signal detection
- Risk management
- Aggregate safety reporting
- Medical data review
- Clinical interpretation
- Communication
- Collaboration
- Organizational skills
- Planning skills
- Scientific data analysis
- Medical data presentation
Location
- London, UK
Work Type
- Hybrid
Experience Level
- Director level
- Minimum 7 years experience
Education Level
- MBBS or equivalent (physician by training)
About the Company
- 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, potentially curative cell and gene therapies.
- Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.