Sr Business Analyst (Pharmacovigilance & AI Systems) in भारत

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Sr Business Analyst (Pharmacovigilance & AI Systems) based in India. We are seeking an experienced Business Analyst to help shape AI-enabled pharmacovigilance systems that support drug safety, regulatory compliance, and improved patient outcomes. In this role, you will translate complex business, clinical, technical, and regulatory needs into clear, testable requirements for software platforms used across the pharmacovigilance lifecycle. You will collaborate closely with safety operations specialists, quality teams, data privacy experts, product managers, data scientists, and engineers to deliver reliable, inspection-ready solutions. A key focus will be defining how AI and agentic systems support activities such as adverse event intake, literature screening, signal detection, and regulatory reporting while maintaining appropriate human oversight. You will also help ensure that systems meet applicable GxP, data integrity, privacy, and computerised system validation requirements. This opportunity is ideal for a detail-oriented professional who combines strong requirements engineering skills with pharmacovigilance expertise and a practical understanding of AI in regulated environments.

Accountabilities - Lead requirements engineering: Elicit, document, review, and maintain User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) through stakeholder workshops, process walkthroughs, system demonstrations, SOP reviews, and structured discussions with subject-matter experts. - Develop clear requirements documentation: Create and maintain process maps, data-flow diagrams, user stories, acceptance criteria, business rules, data dictionaries, interface specifications, and non-functional requirements covering performance, availability, security, auditability, and data retention. - Maintain requirements traceability: Build and manage a Requirements Traceability Matrix linking user and functional requirements to system design, test cases, and validation evidence, ensuring requirements remain verifiable throughout delivery. - Coordinate stakeholder reviews and change control: Work with pharmacovigilance operations, Quality Assurance, IT Security, Data Privacy, Engineering, and Product Management to validate requirements, manage approved changes, prioritize features, define release scope, and support Agile planning and backlog refinement. - Specify literature screening and adverse event intake workflows: Define requirements for literature search strategies, database integrations, duplicate detection, AI-assisted relevance screening, Individual Case Safety Report (ICSR) identification, multi-channel intake, automated data extraction, medical coding support, narrative generation, follow-up management, and E2B(R3) submissions. - Support signal management and regulatory reporting: Translate business needs into requirements for safety data retrieval, signal detection and assessment, prioritization, tracking, periodic safety reports, source-to-text traceability, author and reviewer workflows, version control, and submission tracking. - Define digital and social media monitoring capabilities: Specify source configurations, monitoring rules, AI-based adverse event classification, patient information handling, validity assessment, reviewer workflows, and the conversion of relevant findings into case intake processes. - Enable quality oversight and compliance monitoring: Define requirements for Pharmacovigilance System Master File (PSMF) support, audit-trail reporting, compliance dashboards, deviation and Corrective and Preventive Action (CAPA) tracking, training evidence retrieval, and the reproducibility of AI-assisted decisions.