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EY

Senior Regulatory Compliance, PV, BA

EY

Senior Consultant for Regulatory Compliance focusing on Veeva Vault Safety at EY. Leading business analysis activities, supporting global pharmacovigilance technology transformation programs.

Posted 5/22/2026full-timeKolkata • 🇮🇳 IndiaSeniorWebsite

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, PharmD, Nursing, or related field
  • 4-8 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.

Benefits

Comp & perks
  • 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
business analysisrequirements gatheringprocess mappinggap-fit analysispharmacovigilancedata migrationdata mappingdata quality validationreportinganalytics
Soft Skills
stakeholder managementcommunicationmentoringteamworkindependencechange managementrisk identificationissue escalation