Veeva Vault Safety Business Analyst

Responsibilities

• Lead business analysis activities for Veeva Vault Safety initiatives, including requirements gathering, process mapping, and gap fit analysis.
• Facilitate stakeholder workshops to document business and functional requirements (BRD/FRD) with full traceability.
• Analyze end-to-end pharmacovigilance processes, including case intake, ICSR workflows, coding (MedDRA/WHODrug), and regulatory submissions.
• Act as a bridge between business, configuration, quality, and technical teams to ensure regulatory intent and GxP compliance are met.
• Support data migration activities through legacy system analysis, data mapping, and quality validation rules.
• Define reporting and analytics requirements, including PV KPIs and dashboards using Power BI.
• Support testing activities by defining UAT strategies, authoring test scenarios, and coordinating defect triage.

Requirements

• Bachelor's or master's degree in Life Sciences, Biotech, Pharmacy, PharmD, or Nursing.
• 8+ years of experience in pharmacovigilance systems.
• Hands-on exposure to Veeva Vault Safety configuration and validation.
• Strong knowledge of global drug safety regulations, including FDA, EMA, and ICH guidelines.
• Proficiency in Power BI for creating analytical reports and dashboards.
• Experience working in consulting or global delivery models within the life sciences sector.

Preferred Qualifications

• Experience working with Japanese regulatory requirements (PMDA).
• Previous exposure to clinical trial safety and safety database implementation.
• Certification in pharmacovigilance or drug safety (e.g., DIA, RAPS).
• Experience with Computer System Validation (CSV) of GxP systems.

Benefits

• Support, coaching, and feedback from engaging colleagues.
• Opportunities to develop new skills and progress your career through individual progression plans.
• A flexible work environment that allows you to handle your role in a way that works for you.
• The chance to work on meaningful, large-scale global transformation programs.

About the Company

EY is a global leader in assurance, consulting, tax, strategy, and transactions. We are dedicated to building a better working world by helping clients navigate complex regulatory landscapes and leveraging advanced technology to shape the future with confidence.