Senior Business Analyst, Pharmacovigilance – AI Systems

🔥 4 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧐 Business Analyst

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EVERSANA

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

🏥 Healthcare

⚕️ Healthcare Insurance

Consulting • Healthcare • Healthcare Insurance

EVERSANA is a comprehensive service provider focused on integrated commercial solutions for the life sciences industry. The company offers a wide range of services including advisory and management consulting, regulatory consulting, patient services, market access strategies, pricing and revenue management, medical affairs, and digital transformation. EVERSANA is known for its expertise in drug commercialization, enabling companies to effectively launch and manage pharmaceutical products. With a platform powered by data and analytics, EVERSANA addresses challenges related to drug pricing, market access, patient adherence, and product delivery, helping companies optimize their commercial strategies and enhance patient outcomes. The company emphasizes innovation and has been recognized for its use of AI and data analytics within the life sciences sector.

📋 Description

• 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, case intake, signal detection, 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, explainability, auditability, guardrails, fallback behavior and model lifecycle governance • Translate regulatory, quality, privacy and computerised-system-validation requirements into explicit, testable requirements • Support validation plans, risk assessments, test strategies and traceability • Act as requirements-side point of contact during audits and regulatory inspections • Work with PV operations, medical reviewers, Quality Assurance, Data Privacy, IT Security, product management, UX, data scientists and engineers • Support UAT, coordinate testers, triage defects and confirm requirement coverage • Prepare release notes, functional documentation and training inputs • Contribute to client-facing materials describing regulatory compliance

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science or a related field • 6+ years in pharmacovigilance or PV systems • 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 listed 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 working within a 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 involvement in an AI or automation project in PV strongly preferred • Strong analytical writing skills • Comfortable with Agile delivery and Jira, Confluence or Azure DevOps • Preferred experience with E2B(R3), MedDRA, WHODrug, EudraVigilance or FAERS • Experience specifying NLP, machine-learning or GenAI features with 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 participation in regulatory inspections or client audits of PV systems • Certifications such as CBAP, PMI-PBA or ISPE/GAMP training preferred

🏖️ Benefits

• Certified as a Great Place to Work across the globe • Equal Opportunity Employer • Inclusive culture embracing diversity, equity and inclusion • Employee development and investment in development of others • Global team collaboration opportunities • Remote work option

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