Senior Business Analyst, Pharmacovigilance, AI Systems

EVERSANA

. Elicit, document and maintain URS and FRS for platform modules .

Posted 10/12/2026full-timeRemote • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in eliciting and documenting user requirements specifications (URS) and functional requirements specifications (FRS) for pharmacovigilance systems, with a strong focus on regulatory compliance and validation processes. Proficient in Agile methodologies and tools, ensuring effective collaboration across cross-functional teams in a regulated environment.

Highest-signal resume keywords

Pharmacovigilance Systems ExperienceURS And FRS AuthoringAgile MethodologiesRegulatory Compliance KnowledgeCommercial Safety Database Familiarity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Requirements TraceabilityData-Flow DiagramsProcess MappingValidation DocumentationChange Control ManagementAI Acceptance Criteria SpecificationRegression TestingData Integrity PrinciplesQMS And SDLC ExperienceAnalytical Writing

Soft Skills

CollaborationAnalytical ThinkingCommunication

Tools & Technologies

JiraConfluenceAzure DevOpsArgusLifeSphereVeeva Vault Safety

Certifications & Qualifications

CBAPPMI-PBAISPE/GAMP Training

Industry Keywords

GxP Software21 CFR Part 11EU GMP Annex 11GDPRE2B(R3)MedDRAWHODrugEudraVigilanceFAERSGAMP 5

Tech Stack

Tools & technologies

AzureSDLCVault

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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