Director, Pharmacovigilance

The Director, Pharmacovigilance is a safety expert with medical/scientific knowledge on the safety and benefit-risk profile of one or more Orchard products that can be in the investigational and/or marketed phase of its life cycle. In addition to being an integral part of the safety team for assigned product safety activities, this position would be the Orchard PV lead responsible for global medical product-related activities. The Director, Pharmacovigilance works in close collaboration with the other cross-functional leads to seamlessly and proactively draft/implement a strategic programme/product specific benefit-risk plan and support or directly interface with Health Authorities in all geographies as appropriate on product safety issues and product filings.

As an experienced medical monitor, the Director, Pharmacovigilance will provide medical and clinical oversight for one or more gene therapy programmes. This role is critical in ensuring the safety of participants, the integrity of clinical data, and the compliance of studies with regulatory and ethical standards.

Key Elements and Responsibilities

• Support the Head of PV in the oversight of the PV systems including the Veeva safety database and other systems to meet our global regulatory requirements.
• Leads and collaborates on strategy, review, and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs.
• Leads the core risk management strategy, risk assessment and risk minimisation measures for Orchard products for which they are the global safety lead with other head of the functions and has oversight of risk management plans (RMPs), pharmacovigilance plans etc.
• With support from the PV Scientist(s), leads the signal management process (i.e., signal detection, and chairs safety management meetings, etc.) for post-marketing product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities for investigational products.
• Includes synthesis of data from multiple sources and authoring signal evaluation reports.
• Leads signal review process and product safety management team meetings.
• Provides internal training on signal management activities, when needed.
• Supports the PV scientist in responding to safety questions from internal and external stakeholders and also serves as a subject matter expert for the pharmacovigilance team and cross-functional teams on relevant global safety regulations and guidelines.
• Review and analysis of safety data from post-marketing sources and from clinical trials.
• Provides input into global literature monitoring strategy as needed as part of post-marketing monitoring requirements.
• Review and management of benefit-risk profile for assigned compounds and products.
• Provides input, reviews, contributes and when requested leads responses to safety questions from regulatory authorities.
• Effectively communicates safety issues to relevant stakeholders within Orchard including senior management.
• Works with the clinical programs as a medical pharmacovigilance advisor/subject matter expert.
• Collaborates with other teams for assigned investigational programmes including clinical trial activities (protocol review, ICF review, etc.), data analysis, ad-hoc requests and other product activities, as assigned.
• Provides clinical sponsor oversight and review of SAEs.
• Collaborates with other cross-functional team members for assigned investigational programmes including clinical trial activities (protocol review, ICF review, line listings, etc.), safety committee management, data analysis, signal detection, ad-hoc requests and other product activities, as assigned.
• Conduct ongoing medical data review and provide timely clinical interpretation of emerging data.
• Perform regular, planned, listings, coding, and protocol deviation reviews, following the medical monitoring plan.
• Review listings, tables, and figures during database lock preparation to ensure clinical coherence and consistency.
• Perform real-time safety monitoring of trial participants, including medical review of adverse events (AEs) and serious adverse events (SAEs), and develop queries for data clarification.
• Where required, review and provide medical input into clinical study documents, including protocols, amendments, informed consent forms, and investigator brochures.

Requirements

Education, Experience & Knowledge

• Minimum 7 years experience in the pharmaceutical industry or clinical care setting.
• Director level with an MBBS or equivalent (physician by training).
• Demonstrated experience in drug safety (minimum 3-5 years) which includes prior direct interactions with EU and ROW regulatory authorities.

Desired:

• Experience in managing PV scientist(s) overseeing activities for assigned compounds/products.

Skills & Abilities

• Demonstrated success working as a physician in a pharmacovigilance department and 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 organisational and planning skills.
• Understands, interprets, analyses and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Develop and maintain relationships with programme counterparts in Clinical Development, Regulatory, Clinical Operations, Medical Affairs and other internal departments.
• Demonstrate ability to lead and collaborate within highly complex organisations and across functions and geographies.