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Regulatory Compliance, Veeva Safety – BA Manager
EYBusiness Analyst in EY's Regulatory Compliance team, focusing on Veeva Vault Safety solutions. Working with clients on patient safety and regulatory compliance projects, ensuring quality deliverables.
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Partner with pharmacovigilance and quality stakeholders to define and translate business needs into clear functional requirements for Vault Safety
- Support clients in strengthening patient safety, inspection readiness, and system governance
- 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)
- Analyze end to end pharmacovigilance processes including case intake, ICSR workflows, coding (MedDRA / WHODrug), medical review, and regulatory submissions
- Act as a bridge between business, configuration, quality, and technical teams to ensure regulatory intent is met
- Define reporting and analytics requirements including PV KPIs, dashboards, signal management, and aggregate reporting needs
Requirements
What you’ll need- 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
- 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
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Veeva Vault Safetypharmacovigilancerequirements gatheringprocess mappinggap fit analysisadverse event reportingcodingregulatory submissionsreporting and analyticsdashboard creation
Soft Skills
communicationstakeholder managementleadershipcollaborationanalytical thinkingproblem-solvingfacilitationorganizational skillsflexibilityinterpersonal skills