Global professional services leader EY (Ernst & Young) is hiring experienced professionals for the position of Senior Consultant – Veeva Vault Safety Configuration Specialist in Bengaluru, India. This opportunity is ideal for candidates with experience in pharmacovigilance systems, Veeva Vault Safety configuration, drug safety operations, regulatory compliance, and GxP validation.
Professionals with backgrounds in pharmacy, life sciences, biotechnology, nursing, and pharmacovigilance who have worked on global safety databases and regulatory compliance projects can explore this exciting career opportunity with EY Global Delivery Services (GDS).
Job Details
| Job Title | Senior Consultant – Veeva Vault Safety |
|---|---|
| Company | EY (Ernst & Young) |
| Department | Regulatory Compliance – Pharmacovigilance |
| Location | Bengaluru, Karnataka, India |
| Experience | 4–8 Years |
| Qualification | Bachelor’s or Master’s Degree |
| Industry | Pharmacovigilance, Drug Safety, Regulatory Compliance |
| Job Type | Full-Time |
Key Responsibilities
The selected candidate will:
- Configure Veeva Vault Safety workflows, lifecycles, templates, objects, and business rules.
- Support pharmacovigilance case intake, triage, processing, review, and regulatory submissions.
- Translate global PV regulations and client SOP requirements into compliant system configurations.
- Manage role-based access controls, security settings, and data governance.
- Collaborate with Computer System Validation (CSV) teams.
- Participate in regulatory inspections, audits, and quality assessments.
- Support inspection readiness and compliance monitoring activities.
- Work closely with Pharmacovigilance, Quality Assurance, Regulatory Affairs, and IT stakeholders.
- Mentor junior team members and contribute to organizational initiatives.
Required Qualifications
Candidates should possess:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Nursing, or related disciplines.
- 4–8 years of experience in pharmacovigilance systems.
- Hands-on expertise in Veeva Vault Safety configuration and validation.
- Strong understanding of adverse event reporting and global drug safety processes.
- Knowledge of FDA, EMA, ICH, and GVP guidelines.
- Experience supporting regulated life sciences organizations.
- Strong communication and stakeholder management skills.
Must-Have Skills
- Veeva Vault Safety configuration
- Pharmacovigilance systems management
- GxP compliance and Computer System Validation (CSV)
- Workflow and lifecycle configuration
- Security and access management
- E2B(R3) integrations
- Data migration support
- Reporting and analytics dashboards
- Regulatory submissions compliance
- Requirements gathering and solution design
- Testing and validation methodologies
Preferred Skills
- PMDA regulatory knowledge and experience with Japanese clients
- Pharmacovigilance workflow expertise
- Safety database implementation and testing
- DIA or RAPS certifications
- Advanced GxP documentation and validation experience
Why Join EY?
EY offers professionals the opportunity to work on global pharmacovigilance transformation projects and regulatory compliance programs.
Benefits include:
- Exposure to global life sciences clients
- Career growth opportunities
- Continuous learning and professional development
- Flexible work environment
- Mentorship from industry experts
- Participation in large-scale regulatory compliance projects
- International consulting exposure
Who Should Apply?
This role is suitable for:
- Pharmacovigilance Specialists
- Drug Safety Associates
- Safety Database Administrators
- Veeva Vault Safety Consultants
- Regulatory Compliance Professionals
- Computer System Validation Specialists
- Clinical Safety Operations Professionals
How to Apply
