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 programs 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 programs 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.