Sr Business Analyst (Pharmacovigilance & AI Systems)

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 the human-in-the-loop checkpoints where a qualified person must review approve or override.
• Specify AI output acceptance criteria with the SMEs: target precision and recall for screening and classification tasks confidence thresholds for auto-routing versus human review and how performance is measured and monitored in production.
• Write requirements for explainability and auditability of AI decisions: rationale capture source citation prompt and model version logging reproducibility and retention of the evidence an inspector would ask for.
• Specify guardrails: what agents must never do without human approval (e.g. submit an ICSR close a signal finalise a report) handling of low-confidence or out-of-distribution inputs and fallback behaviour when a model or tool is unavailable.
• Define requirements for model lifecycle governance: evaluation datasets change control for prompts and models regression testing periodic review and restrictions on use of client data for model training.

Regulatory quality and privacy compliance

• Translate the following into explicit testable requirements and work with Quality on validation strategy:
  • 21 CFR Part 11 and EU GMP Annex 11: electronic records electronic signatures audit trails access control data integrity (ALCOA) system security record retention and retrieval.
  • GDPR and other applicable data-protection laws: lawful basis data minimisation pseudonymisation data-subject rights cross-border transfer retention and deletion privacy by design; support Data Protection Impact Assessments.
  • GVP Modules (notably I II IV VI VII IX) and ICH E2B(R3) E2C(R2) E2D E2E as they apply to each module.
  • Computerised system validation: GAMP 5 (second edition) risk-based and Computer Software Assurance approaches; author or contribute to validation plans functional risk assessments test strategies and traceability.
  • Quality Management System requirements for product development: SDLC procedures change control deviation and CAPA management supplier qualification documentation standards; alignment with ISO 9001 and information-security frameworks (ISO 27001 SOC 2).
  • Emerging AI-specific regulation and guidance (EU AI Act FDA and EMA positions on AI in pharmacovigilance and GxP): assess applicability track developments and reflect them in requirements.
• Act as the requirements-side point of contact during internal audits and client or regulatory inspections of the platform.

Stakeholder and delivery

• Work day-to-day with PV operations leads medical reviewers Quality Assurance Data Privacy IT Security product management UX data scientists and engineers.
• Support UAT: author or review test scripts against the FRS coordinate business testers triage defects and confirm requirement coverage.
• Prepare release notes user-facing functional documentation and training inputs for operations teams.
• Contribute to client-facing material describing how the platform meets regulatory expectations.

Qualifications :

MINIMUM KNOWLEDGE SKILLS AND ABILITIES

• Bachelors degree in life sciences pharmacy nursing medicine computer science or a related field.
• 6 years in pharmacovigilance or PV systems with at least 3 years in a business analyst systems analyst or product requirements role on GxP software.
• Demonstrated experience authoring URS and FRS (and ideally validation documentation) for PV or other regulated life-sciences systems.
• Working knowledge of at least four of the six domain areas above gained in operations a safety-system implementation or a technology vendor; 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 and of how 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 what it takes to make their output acceptable in a regulated setting. Prior involvement in an AI or automation project in PV is strongly preferred.
• Strong analytical writing: you can produce a requirement that an engineer can build a tester can test and an auditor can verify without ambiguity.
• Comfortable with Agile delivery and tools such as Jira Confluence or Azure DevOps.

Preferred

• Experience with E2B(R3) implementation MedDRA and WHODrug coding and EudraVigilance or FAERS data.
• Experience specifying NLP machine-learning or GenAI features (classification extraction summarisation) including evaluation metrics and acceptance criteria.
• Familiarity with GAMP 5 second edition and the FDA Computer Software Assurance approach.
• Awareness of the EU AI Act and of EMA/FDA reflection papers on AI in the medicinal-product lifecycle.
• Prior participation in regulatory inspections or client audits of PV systems.
• Certifications such as CBAP PMI-PBA or ISPE/GAMP training.

Additional Information :

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others. 
Win Together I passionately connect with anyone anywhere anytime to achieve results.
Communication Matters I speak up to create transparent thoughtful and timely dialogue.
Embrace Diversity I create an environment of awareness and respect.
Always Innovate I am bold and creative in everything I do.

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From EVERSANAs inception Diversity Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer and our employees are people with different strengths experiences and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity but also age disability status veteran status sexual orientation religion and many other parts of ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

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Remote Work :

Yes

Employment Type :

Full-time