Job Title
Senior Consultant – Regulatory Compliance (PV) – Veeva Vault Safety Configuration Specialist
Company
EY (Ernst & Young) – GDS Consulting, Enterprise Risk (Regulatory Compliance)
Location
Bangalore, India (Primary location)
Employment Type
Full-time (Consulting role)
Job Posting Date
29 May 2026
Requisition ID: 1710976
Role Summary
This role focuses on pharmacovigilance (PV) system consulting and configuration, specifically working on Veeva Vault Safety to support global drug safety operations. It combines technology configuration, regulatory compliance, and PV domain expertise to build and maintain compliant safety systems for life sciences clients.
Key Responsibilities
Veeva Vault Safety Configuration
Configure Veeva Vault Safety modules including:
Workflows
Lifecycles / state models
Objects, fields, and templates
Business rules
Design and maintain role-based access controls and security models
Ensure GxP-compliant system configurations
Pharmacovigilance System Support
Translate global PV regulations and client SOPs into system design
Support case intake, triage, processing, review, and submission workflows
Ensure compliance with:
ICH guidelines
GVP (Good Pharmacovigilance Practices)
FDA and EMA regulations
Support ICSR (Individual Case Safety Report) processing requirements
Validation, Testing & Compliance
Support CSV (Computer System Validation) activities
Participate in system testing and validation of GxP systems
Ensure data integrity and regulatory compliance
Support audit and inspection readiness activities
Respond to regulatory and quality queries during audits
Integration & Data Management
Support system integrations using APIs and connectors
Assist with E2B(R3) submissions and data migration activities
Maintain dashboards and reporting for PV operational KPIs
Monitor data quality and compliance metrics
Stakeholder & Consulting Responsibilities
Collaborate with:
Pharmacovigilance teams
Regulatory teams
IT and Quality Assurance teams
Work in consulting delivery model for global life sciences clients
Support client audits and regulatory inspections
Provide training, documentation, and change management support
Mentor junior team members
Solution Design & Documentation
Participate in requirements gathering (URS/FRS)
Create configuration specifications and process maps
Support Agile delivery and prototyping
Maintain documentation for system governance
Required Qualifications
Bachelor’s or Master’s in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Related fields
Experience Required
4–8 years of experience in:
Pharmacovigilance systems
Veeva Vault Safety configuration and validation
Regulated life sciences environments
Technical Skills
Core Veeva Skills
Vault Safety configuration:
Workflows
Lifecycle management
Business rules
Data model design
Templates
Compliance & PV Knowledge
Strong understanding of:
ICH, GVP, FDA, EMA regulations
PV processes (ICSR, case processing, seriousness, expectedness)
MedDRA / WHO Drug concepts
Validation & Integration
Computer System Validation (CSV)
System testing and validation
API integrations and data exchange (E2B R3)
Data migration support
Reporting & Analytics
Dashboard creation and PV KPIs
Data quality monitoring and reporting tools
Behavioral Skills
Strong communication and stakeholder management
Analytical and problem-solving mindset
Consulting and client-facing skills
Ability to work in fast-paced global environments
Ability to handle multiple stakeholders and priorities
Preferred Skills
Experience with Japanese regulatory environment (PMDA)
PV certification (DIA, RAPS)
Safety database implementation experience
Advanced knowledge of CSV documentation
Work Environment
Consulting + project-based global delivery model
Hybrid / office-based (Bangalore)
Interaction with global clients and regulatory teams
May require flexible working hours
Core Role Summary (Simple View)
This job is mainly about:
Configuring Veeva Vault Safety PV system
Ensuring pharmacovigilance regulatory compliance
Supporting drug safety workflows and audits
Working in consulting + technology + PV domain mix
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Remote, India | Siliguri |Illinois :
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