Join EY's Regulatory Compliance team as a Manager, specializing in Veeva Safety. This role focuses on global pharmacovigilance technology and regulatory compliance transformations. You will contribute to strengthening patient safety, inspection readiness, and system governance, directly supporting EY's mission to build a better working world.

As a Veeva Vault Safety Business Analyst, you will translate business needs into functional requirements for Vault Safety, ensuring compliant ICSR processing and safety workflows align with global regulations and client SOPs. This is an exciting opportunity to work on impactful projects within a leading global organization.

Lead business analysis for Veeva Vault Safety initiatives, encompassing requirements gathering, process mapping, and gap analysis. Facilitate stakeholder workshops and document business/functional requirements with full traceability. Analyze end-to-end pharmacovigilance processes, including case intake, ICSR workflows, coding, medical review, and submissions.

Review Vault Safety architecture against requirements to ensure solution design integrity. Serve as a liaison between business, configuration, quality, and technical teams. Support change management, training needs analysis, and post-go-live governance. Provide business analysis for data migration, including legacy system analysis and data mapping.

Define reporting and analytics requirements for PV KPIs, dashboards, and aggregate reporting. Support project leadership with stakeholder management, sprint planning, risk identification, and issue escalation. Mentor junior analysts and contribute to internal knowledge sharing initiatives.

A Bachelor's or Master's degree in Life Sciences, Biotech, Pharmacy, PharmD, Nursing, or a related field is required. You should have 8+ years of experience in pharmacovigilance systems, with hands-on exposure to Veeva Vault Safety configuration and validation. A strong understanding of pharmacovigilance processes, global regulatory reporting, and related timelines is essential.

Experience in consulting or global delivery models supporting regulated life sciences clients is expected. Knowledge of global drug safety regulations, including FDA, EMA, and ICH guidelines, is crucial. Excellent communication skills are necessary for effective interaction with internal teams and external stakeholders. Proficiency in dashboard and PV-related analytical report creation using tools like Power BI is beneficial.

Must-have attributes include owning business analysis delivery for Veeva Vault Safety programs, facilitating workshops, and analyzing pharmacovigilance processes. Partnering with configuration and technical teams to review Vault Safety design and acting as the primary liaison across business, quality, and technical teams are key. Supporting testing, data migration, and reporting requirements are also critical. The ability to work independently and as part of a team in a fast-paced, regulated environment is expected.