Sr Business Analyst (Pharmacovigilance & AI Systems)

Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job 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.

Agentic AI specifics

• Define, for every agent in the platform, its role, inputs, tools, permitted actions and decision authority, and t…