Senior Business Analyst, Pharmacovigilance, AI Systems

• Elicit, document and maintain URS and FRS for platform modules
• Produce process maps, data-flow diagrams, user stories, business rules, data dictionaries, interface specifications and non-functional requirements
• Build and maintain requirements traceability from URS through validation evidence
• Run requirement reviews with PV operations, Quality, IT Security, Data Privacy and Engineering
• Manage change control, prioritize with the Product Owner and support sprint planning and backlog refinement
• Specify requirements across pharmacovigilance literature, intake, case processing, signal management, aggregate reporting, social media monitoring and compliance modules
• Define agent roles, inputs, tools, permitted actions, decision authority and human-in-the-loop checkpoints
• Specify AI acceptance criteria, confidence thresholds, monitoring, explainability, auditability, guardrails and fallback behavior
• Define model lifecycle governance, evaluation datasets, regression testing and restrictions on client-data training
• Translate regulatory, quality, privacy and computer-system-validation requirements into explicit, testable requirements
• Support validation plans, risk assessments, test strategies and traceability
• Act as requirements-side contact during audits and regulatory inspections
• Work with PV operations, medical reviewers, QA, Data Privacy, IT Security, product, UX, data scientists and engineers
• Support UAT, coordinate testers, triage defects and confirm requirement coverage
• Prepare release notes, functional documentation, training inputs and client-facing regulatory materials

• Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science or a related field
• 6+ years in pharmacovigilance or PV systems, including at least 3 years in a business analyst, systems analyst or product requirements role on GxP software
• Experience authoring URS and FRS, ideally validation documentation, for PV or regulated life-sciences systems
• Working knowledge of at least four of the six domain areas
• Hands-on familiarity with at least one commercial safety database: Argus, LifeSphere, Veeva Vault Safety or equivalent
• Understanding of 21 CFR Part 11, EU GMP Annex 11, data-integrity principles and GDPR
• Experience with QMS and formal SDLC, including change control, CSV/CSA, traceability and deviation handling
• Practical understanding of LLMs and AI agents, their failure modes and regulated-output requirements
• Prior AI or automation project in PV strongly preferred
• Strong analytical writing
• Comfortable with Agile delivery and Jira, Confluence or Azure DevOps
• Preferred: E2B(R3), MedDRA, WHODrug, EudraVigilance or FAERS experience
• Preferred: NLP, machine-learning or GenAI feature specification, including evaluation metrics and acceptance criteria
• Familiarity with GAMP 5 second edition and FDA Computer Software Assurance
• Awareness of the EU AI Act and EMA/FDA AI reflection papers
• Prior regulatory-inspection or client-audit participation
• Certifications such as CBAP, PMI-PBA or ISPE/GAMP training

• Great Place to Work certification
• Equal Opportunity Employer
• Diversity, Equity & Inclusion commitment