RC-REGULATORY COMPLIANCE-Veeva Safety - Configuration-Manager

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.

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, PharmD, Nursing, or related field.
• 8+ years of experience in pharmacovigilance systems with hands‑on exposure to Veeva Vault Safety configuration and validation.
• Strong understanding of pharmacovigilance processes, adverse event reporting requirements for multiple regions, and related regulatory timelines.
• Experience working in consulting or global delivery models supporting regulated life sciences clients
• Knowledge of global drug safety regulations including but not limited to FDA, EMA, ICH guidelines.
• Ability to work independently and as part of a team in a fast-paced, regulated environment.
• Strong communication skills to interact effectively with internal teams and external stakeholders.
• Proficiency for dashboard and PV related analytical reports creation using Power BI and similar tools
• Willingness to work flexible hours or shifts, if required.

Must-Have Skills & Attributes

• Own business analysis delivery for Veeva Vault Safety programs, including scope definition, requirements elicitation, process mapping, and gap fit assessment.
• Facilitate stakeholder workshops and interviews; document business and functional requirements (BRD/FRD/URS) with end-to-end traceability.
• Analyze end to end pharmacovigilance processes (case intake, triage, ICSR processing, MedDRA/WHODrug coding, medical review, submissions) and translate into Vault Safety solution needs.
• Partner with configuration and technical teams to review Vault Safety design (workflows, lifecycles/state models, object model, business rules) against approved requirements and regulatory intent.
• Act as the primary liaison across business, quality/CSV, and technical teams to ensure GxP expectations, SOP alignment, and inspection readiness are maintained.
• Support testing activities by defining UAT strategy, authoring test scenarios, coordinating defect triage, and supporting the traceability matrix.
• Support data migration and integration requirements, including legacy assessment, data mapping, transformation rules, and data quality/validation criteria.
• Define reporting and analytics needs (PV KPIs, operational dashboards, compliance monitoring, signal/aggregate reporting support) and validate outputs with stakeholders.
• Support delivery leadership with backlog grooming/sprint planning, RAID management, status reporting, and stakeholder communications.
• Support change management and adoption (training materials, role-based guidance, SOP impacts) and contribute to internal knowledge sharing/mentoring.

Good-to-Have Skills & Attributes

• Experience in working for Japanese clients with understanding of latest regulatory requirements for PMDA.
• Knowledge of PV processes.
• Previous exposure to clinical trial safety.
• Safety Database testing and implementation.
• Certification in pharmacovigilance or drug safety (e.g., DIA, RAPS), Medical Dictionary coding is a plus.
• Computer system validation of GxP systems including Safety systems and creation/review of system documentation.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you