Senior Business Analyst, Pharmacovigilance – AI Systems

This is a fully remote position, open to applicants in India.

📋 Description

• Gather, document, and uphold User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for platform components.

• Create process maps, data-flow diagrams, user stories, business rules, data dictionaries, interface specifications, and non-functional requirements.

• Establish and sustain requirements traceability from URS through validation evidence.

• Conduct requirement reviews with Pharmacovigilance (PV) operations, Quality, IT Security, Data Privacy, and Engineering teams.

• Oversee change control, prioritize tasks with the Product Owner, and assist in sprint planning and backlog refinement.

• Define requirements across pharmacovigilance literature, case intake, signal detection, aggregate reporting, social media monitoring, and compliance modules.

• Outline 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.

• Convert regulatory, quality, privacy, and computerized system validation requirements into clear, testable criteria.

• Assist in validation plans, risk assessments, test strategies, and traceability.

• Serve as the requirements-side contact during audits and regulatory inspections.

• Collaborate with PV operations, medical reviewers, Quality Assurance, Data Privacy, IT Security, product management, UX, data scientists, and engineers.

• Facilitate User Acceptance Testing (UAT), coordinate testers, triage defects, and ensure requirement coverage.

• Draft release notes, functional documentation, and training materials.

• Contribute to client-facing documents that outline regulatory compliance.

⛳️ Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science, or a related field.

• Over 6 years of experience in pharmacovigilance or PV systems.

• A minimum of 3 years in a business analyst, systems analyst, or product requirements role within GxP software.

• Proficient in authoring URS and FRS, ideally including validation documentation for PV or regulated life sciences systems.

• Working knowledge of at least four of the six specified domain areas.

• Hands-on experience 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 Quality Management System (QMS) and formal Software Development Life Cycle (SDLC), including change control, Computerized System Validation (CSV)/Computer System Assurance (CSA), traceability, and deviation management.

• Practical knowledge of Large Language Models (LLMs) and AI agents, including their failure modes and regulated output requirements.

• Prior engagement in an AI or automation project within PV is strongly preferred.

• Excellent analytical writing abilities.

• Comfortable with Agile methodologies and tools such as Jira, Confluence, or Azure DevOps.

• Preferred familiarity with E2B(R3), MedDRA, WHODrug, EudraVigilance, or FAERS.

• Experience in specifying NLP, machine learning, or GenAI features with evaluation metrics and acceptance criteria.

• Knowledge of GAMP 5 second edition and FDA Computer Software Assurance.

• Awareness of the EU AI Act and EMA/FDA AI reflection papers.

• Previous participation in regulatory inspections or client audits of PV systems.

• Certifications such as CBAP, PMI-PBA, or ISPE/GAMP training are preferred.

🏝️ Benefits

• Recognized as a Great Place to Work globally.

• Equal Opportunity Employer.

• Inclusive culture that values diversity, equity, and inclusion.

• Commitment to employee development and investment in the growth of others.

• Opportunities for global team collaboration.

• Option for remote work.