Orchard Therapeutics
Director, Pharmacovigilance
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Director, Pharmacovigilance
Reporting to: VP Pharmacovigilance Location: London, UK / Hybrid
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. Located in London, Orchard is a wholly owned subsidiary of Kyowa Kirin, a Japan-based global specialty pharmaceutical company.
Job Summary
The Director, Pharmacovigilance (Director, PV) is a safety expert with medical/scientific knowledge on the safety and benefit-risk profile of one or more Orchard products, applicable to products in the investigational and/or marketed phases of their lifecycle.
Beyond essential contributions to product safety activities, this global PV lead collaborates with cross-functional teams to strategically design, implement, and refine product-specific benefit-risk plans, and engages health authorities globally on regulatory matters.
As an experienced medical monitor, this role ensures the safety of participants, the integrity of clinical data, and compliance with regulatory and ethical standards for assigned gene therapy programs.
Key Elements and Responsibilities
Global Pharmacovigilance Oversight
- Support the Head of PV in managing PV systems, including the Veeva safety database, to ensure global regulatory compliance.
- Lead and collaborate on the strategy, review, and finalisation of aggregate safety reports, such as PSURs (Periodic Safety Update Reports) and DSURs (Development Safety Update Reports).
Regulatory and Risk Management Leadership
- Drive core risk management strategies, including risk assessment and risk minimization measures, for Orchard products as a global safety lead, overseeing Risk Management Plans (RMPs) and pharmacovigilance plans.
- Liaise with regulatory authorities (EU, UK, FDA, and ROW) on safety issues and product filings.
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Signal Management and Safety Data Review
- As part of the PV scientist(s), lead signal management processes, including:
- Signal detection and chairs safety management meetings
- Data analysis for post-marketing and ongoing safety activities of both investigational and marketed products
- Authoring signal evaluation reports
- Manage benefit-risk assessments for assigned compounds.
- Provide internal training on signal management, as needed.
Clinical Research and Compliance
- Act as a medical pharmacovigilance advisor for clinical programs, including protocol review, interventional committee independence (ICF) assessments, and data analysis.
- Provide medical monitoring oversight in clinical trials, real-time SAE (serious adverse event) review, and development of clarification queries.
- Oversee planned listings, coding, and protocol deviation reviews.
- Ensure clinical coherence and consistency in listings, tables, and figures during database lock preparations.
Regulatory Engagement
- Serve as a subject matter expert on global health authority (PHA) regulations and guidelines for internal and external audiences.
- Lead or contribute to responses to regulatory authorities on safety questions.
- Review and provide medical input into clinical documents, such as protocols, amendments, informed consent forms (ICFs), and investigator brochures.
Stakeholder Collaboration
- Communicate safety issues to internal stakeholders, including senior management.
- Collaborate with clinical, regulatory, and medical affairs teams on gene therapy programs, including data analysis, ad-hoc requests, and cross-functional project management.
- Provide timely clinical interpretation of emerging medical data and ongoing medical safety reviews, maintaining compliance with global guidelines.
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Education, Experience & Knowledge
Ideal Requirements
- Minimum 7 years of relevant experience in the pharmaceutical industry or clinical care.
- Director-level medical professional with MBBS or equivalent qualifications (physician by training).
- 3-5 years of experiential drug safety writing with EU and ROW regulatory interactions.
- Strong understanding of GCP, ICH guidelines, and pharmacovigilance practices.
Preferred Working Experience
- Experience in directly managing one or more PV scientists for assigned products or compounds.
Skills & Abilities
- Medical expertise with global regulatory proficiency (EU, UK, US FDA, and ROW).
- Demonstrable medical monitor experience in clinical trials (Phases I/II), preferably in gene therapy.
- Colleagueship in neurometabolic disease.
- Independent problem-solving skills, deliverable management, and adaptability in dynamic research environments.
- Excellent attention to detail for grammar, editorial review, and proofreading of scientific content.
- Strong organisational skills with planning and time management abilities.
- Ability to interpret complex medical and scientific data, and to present findings clearly in verbal and written format.
- Capacity to build rapport with cross-functional partners, including Clinical Development, Regulatory Affairs, Clinical Operations, and Medical Affairs teams.
- Leadership in multidisciplinary teams, ensuring project efficacy and compliance across geographies.
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