Sr Business Analyst (Pharmacovigilance & AI Systems)

ESSENTIAL DUTIES AND RESPONSIBILITIES Requirements Engineering Elicit, document and maintain URS and FRS for each platform module, using structured workshops, process walkthroughs, system demonstrations and review of current SOPs, work instructions and conventions. Produce the supporting artefacts: as-is and to-be process maps, data-flow diagrams, user stories with acceptance criteria, business rules, data dictionaries, interface specifications and non-functional requirements (performance, availability, security, auditability, data retention). Build and maintain the Requirements Traceability Matrix from URS to FRS to design, test cases and validation evidence, so every requirement can be implemented and tested. Run requirement reviews with PV operations, Quality, IT Security, Data Privacy and Engineering; manage change control on approved requirements. Prioritize with the Product Owner, write release-level scope statements and support sprint planning and backlog refinement. Domain coverage You will specify requirements across the following modules, working with the respective PV subject-matter experts: Global and local literature search strategy management, database connectors (MEDLINE/PubMed, Embase and others), de-duplication, AI-assisted relevance screening and ICSR identification, full-text handling, reviewer workflow, hit-level audit trail, reconciliation and KPIs; alignment with GVP Module VI and local literature requirements. Multi-channel intake (email, portal, call c