EVERSANA India Pvt. Ltd
Sr Business Analyst (Pharmacovigilance & AI Systems)
A senior business analyst at EVERSANA in New Delhi writes URS/FRS, traceability matrices and AI acceptance criteria for an agentic-AI pharmacovigilance platform — covering literature screening, case intake, signal detection and reporting — while embedding GxP, 21 CFR Part 11, GAMP 5 and GDPR compliance into requirements.
- Compensation
- Not disclosed
- Location
- New Delhi
- Work setup
- Onsite
- Seniority
- Senior
- Employment
- Full time
- Experience
- 6+ years
- Category
- Business analysis
- Posted
Skills
Must have
- Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science or related field
- 6+ years in pharmacovigilance or PV systems
- At least 3 years as 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 PV domain areas (literature, intake, signal detection, reports, social media, PSMF/compliance)
- Hands-on familiarity with at least one commercial safety database (Argus, LifeSphere, Veeva Vault Safety or equivalent)
- Solid understanding of 21 CFR Part 11, EU GMP Annex 11, data-integrity principles and GDPR as they translate into system requirements
- Experience working within a QMS and formal SDLC (change control, CSV/CSA, traceability, deviation handling)
- Practical understanding of how LLMs and AI agents work, their failure modes, and making their output acceptable in a regulated setting
- Strong analytical writing skills
Nice to have
- Prior involvement in an AI or automation project in pharmacovigilance (strongly preferred)
Full description
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 centre, partner feeds, literature, social media), duplicate detection, AI-assisted data extraction from unstructured sources, MedDRA and WHODrug coding support, seriousness and expectedness assessment, narrative generation with human review, E2B(R3) submission, follow-up management, and integration with safety databases (e.g. Argus, LifeSphere, Veeva Vault Safety).
- Data sources (safety database, EudraVigilance, FAERS, literature), disproportionality and signal detection methods, signal validation, prioritisation, assessment and tracking workflows, signal-to-risk linkage, and documentation aligned to GVP Module IX.
- Data retrieval and reconciliation, line listings and summary tabulations, AI-assisted section drafting with locked source-to-text traceability, author and reviewer workflow, version control, schedule and submission tracking, aligned to 21 CFR 314.80 and ICH E2C(R2).
- Source and channel configuration, listening rules, AI classification of posts for potential adverse events, identifiability and validity criteria, PII handling, reviewer workflow and conversion to case intake, aligned to GVP Module VI and FDA guidance on internet and social media.
- PSMF support, audit-trail reporting and query, compliance dashboards (timeliness, quality, backlog), deviation and CAPA linkage, document and training evidence retrieval, and the ability to reproduce any AI-assisted decision on request.