What are the responsibilities and job description for the Veeva Safety QA / Validation Consultant position at ConfigUSA?
Veeva Safety QA / Validation Consultant
Indianapolis, Indiana, United States-Contract
Job Description – Veeva Safety QA / Validation Consultant
Role Overview
Seeking an experienced QA and Validation professional with expertise in Veeva Safety and Pharmacovigilance systems. The role involves testing, validation, compliance management, and collaboration with cross-functional teams in a regulated GxP environment.
Required Skills
- Veeva Vault
- Veeva Safety
- Pharmacovigilance (PV)
- GxP Validation
- UAT / System Testing / Regression Testing
- IQ/OQ/PQ Documentation
- Traceability Matrix
- JIRA / HP ALM / Quality Center
- 21 CFR Part 11
- ICH E6 / ICH Q9
- EU Annex 11
- MedDRA & WHODrug
- SDLC / GAMP 5
Key Responsibilities
1. Testing & Validation
- Design, develop, and execute:
- Test Plans
- Test Scripts
- Test Cases
- Perform testing for Veeva Safety modules in accordance with GxP validation standards.
- Lead and execute all testing phases:
- Unit Testing
- System Testing
- Integration Testing
- User Acceptance Testing (UAT)
- Regression Testing
- Develop and maintain validation documentation:
- Validation Plans (VP)
- Test Summary Reports (TSR)
- IQ/OQ/PQ Protocols
- Traceability Matrices
- Conduct risk-based testing aligned with:
- ICH Q9
- Company SOPs
- Validate pharmacovigilance workflows including:
- Adverse Event Intake
- Case Processing
- MedWatch / EudraVigilance Submissions
- Safety Signal Workflows
2. Veeva Platform Expertise
- Perform functional and regression testing across Veeva Vault applications.
- Validate:
- Veeva Vault configuration changes
- Workflows
- Object definitions
- Lifecycle state transitions
- Ensure compliance with GxP requirements.
- Test Veeva Vault integrations with third-party clinical and safety systems.
- Support Veeva Vault release upgrades through:
- Impact Assessments
- Regression Testing
- Change Control Validation Activities
- Ensure adherence to:
- 21 CFR Part 11
- Electronic Records & Electronic Signatures compliance
3. Pharmacovigilance & Safety Systems
- Test and validate pharmacovigilance workflows including:
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Reports
- Signal Management
- Validate safety database systems such as:
- Veeva Safety
- Argus Safety
- Support:
- Adverse Event Reporting
- Data Migrations
- Regulatory Submissions
- Collaborate with PV Operations teams to ensure:
- Real-world safety data flow validation
- Regulatory reporting timeline compliance
- 7-day / 15-day expedited reporting
- Validate:
- MedDRA integrations
- WHODrug coding integrations
- Dictionary upgrade impacts