RC-REGULATORY COMPLIANCE-Veeva Safety - Configuration-Manager
Ernst Young · Gurugram · onsite · Posted 44d ago
Undisclosed8–13 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job Summary
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.
- 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.
- Bachelors or masters degree in Life Sciences, Biotech, Pharmacy, PharmD, Nursing, or related field.
- 8+ years of experience in pharmacovigilance systems with handson 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.
- 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.
- Experience in working for Japanese clients with understanding of latest regulatory requirements for PMDA.
- Knowledge of PV processes.
- Previous exposure to clinical trial safety.
Sourced from naukri
Skills
BIOTECHcoding standardsanalytical reportsAggregate ReportingBusiness AnalystCSVBusiness AnalysisAuthoringChange ManagementAnalyticsCompliance MonitoringCapital MarketsCommunication SkillsArchitecturecomplianceArtificial Intelligence
About Ernst & Young
Ernst Young
Management Consulting
44k+
employees
2002
24 years old
Gurgaon / Gurugram, Haryana
India
₹15.3L PA avg
Avg at Ernst & Young
About
At EY, our purpose is Building a better working world. The insights and quality services we provide help build trust and confidence in the capital markets and in economies the world over.
Industries
Management Consulting
Employee ratings
10 reviews
3.4/ 5
Culture
1.9
Career growth
2.3
Work-life
2.5
Employees rate it well for
Job Security36Skill Development35
Find them on