RC-REGULATORY COMPLIANCE-Veeva Safety - Configuration-Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager– Veeva Vault Safety – Business Analyst At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.  Join EY and help to build a better working world.   As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity This role offers the opportunity to work on global pharmacovigilance technology and regulatory compliance transformation programs across multiple jurisdictions. You will support clients in strengthening patient safety, inspection readiness, and system governance, directly contributing to EY’s purpose of Building a better working world.   Role Overview As a Veeva Vault Safety Business Analyst, you will partner with pharmacovigilance and quality stakeholders to define and translate business needs into clear functional requirements for Vault Safety, supporting compliant end to end ICSR processing and related safety workflows in alignment with global regulatory expectations and client SOPs.   Your key responsibilities Client Responsibilities

Lead business analysis activities for Veeva Vault Safety initiatives, including requirements gathering, process mapping, and gap fit analysis. Facilitate stakeholder workshops and document business and functional requirements (BRD / FRD) with full requirements traceability. Analyze end to end pharmacovigilance processes including, but not limited to case intake, ICSR workflows, coding (MedDRA / WHODrug), medical review, and regulatory submissions. Support solution design governance by reviewing Vault Safety architecture, workflows, and object models against approved requirements. Act as a bridge between business, configuration, quality, and technical teams to ensure regulatory intent is met. Support change management and adoption activities including training needs analysis and post go live governance inputs. Provide business analysis support for data migration activities including legacy system analysis, data mapping, and data quality validation rules. Define reporting and analytics requirements including PV KPIs, dashboards, signal management, and aggregate reporting needs, as applicable. Support project leadership activities including stakeholder management, sprint planning support, risk identification, and issue escalation. Mentor junior business analysts and contribute to EY internal knowledge initiatives.

Skills and attributes for success

Strong business analysis skills including requirements elicitation, process mapping, and gap fit analysis in regulated environments. Solid pharmacovigilance domain knowledge including ICSR workflows, safety systems, coding standards, and global regulatory reporting expectations. Ability to assess solution designs against regulatory, business, and GxP requirements. Strong stakeholder communication, facilitation, and consulting skills. Analytical and risk based problem-solving mindset with high attention to quality.

Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, PharmD,