Sr Business Analyst (Pharmacovigilance & AI Systems)

Own the elicitation, documentation, and maintenance of user and functional requirements for multiple pharmacovigilance platform modules, including AI system components, ensuring regulatory and quality compliance.

Build and manage traceability matrices linking requirements to design, test, and validation activities; collaborate with multiple stakeholders across PV operations, Quality, IT Security, and Engineering.

Define AI agent roles, decision authority, acceptance criteria, explainability and auditability features, and governance requirements for AI deployment in regulated PV systems.

Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science, or related field.

Minimum 6 years in pharmacovigilance or PV systems with at least 3 years in business/systems analyst or product requirements role on GxP software.

Experience authoring URS and FRS for PV or regulated life sciences systems; working knowledge of at least 4 of the 6 specified PV domain modules including hands-on familiarity with commercial safety databases (Argus, LifeSphere, Veeva Vault Safety, or equivalent).

Strong understanding of 21 CFR Part 11, EU GMP Annex 11, data integrity principles, GDPR, and working within QMS and formal SDLC processes; practical knowledge of AI and LLM systems in regulated environments.

Experienced in regulated pharmacovigilance system implementation or technology vendor environment with cross-functional collaboration skills involving PV operations, Quality, IT, and data science teams.

Proven ability to translate complex regulatory, quality, and AI governance requirements into clear, testable system requirements and validation documentation.

Comfortable working in Agile environments with tools like Jira, Confluence, or Azure DevOps; able to navigate regulatory audits and client inspections involving PV AI systems.