Veeva Safety Testing Validation

Location: ~Indianapolis, IN~
Duration: 6 months

Role Descriptions: Key Responsibilities
Veeva Safety Testing Validation
Design| develop| and execute test plans| test scripts| and test cases for Veeva Safety modules in accordance with GxP validation standards.
Lead and perform all phases of testing including Unit Testing| System Testing| Integration Testing| User Acceptance Testing (UAT)| and Regression Testing.
Develop and maintain validation documentation including Validation Plans (VP)| Test Summary Reports (TSR)| IQOQPQ protocols| and Traceability Matrices.
Conduct risk-based testing approaches aligned with ICH Q9 and company SOPs.
Validate pharmacovigilance system workflows including adverse event intake| case processing| MedWatchEudraVigilance submissions| and safety signal workflows.
Veeva Platform Expertise
Perform functional and regression testing across Veeva Vault Validate Veeva Vault configuration changes| workflows| object definitions| and lifecycle state transitions in compliance with GxP requirements.
Test Veeva Vault integrations with third-party clinical and safety systems Support Veeva Vault release upgrades by conducting impact assessments| regression testing| and change control validation activities.
Ensure Veeva system configurations adhere to 21 CFR Part 11 electronic records and electronic signatures requirements.
Pharmacovigilance Safety Systems
Test and validate pharmacovigilance workflows including individual case safety reports (ICSRs)| periodic safety reports| and signal management.
Validate safety database systems (e.g.| Veeva Safety| Argus Safety) for adverse event reporting| data migrations| and regulatory submissions.
Collaborate with PV operations teams to ensure testing reflects real-world safety data flows and regulatory reporting timelines (7-day15-day expedited reports).Validate MedDRA and WHODrug coding integrations and dictionary upgrade impacts.
Defect Management Quality AssuranceLog| track| and manage defects using defect tracking tools (e.g.| JIRA| HP ALMQuality Center) through resolution and verification.
Perform root cause analysis on test failures and work with development teams to drive timely remediation.
Collaboration Compliance
Partner with Business Analysts| System Administrators| and end users to review business requirements and translate them into actionable test conditions.
Ensure all validation activities are conducted in compliance with applicable regulations including 21 CFR Part 11| ICH E6 (Google Cloud Platform)| EU Annex 11| and company SOPs.
Contribute to the development and continuous improvement of QA testing standards| templates| and processes.
Maintain accurate and audit-ready test documentation throughout the system development lifecycle (SDLCGAMP 5).

Salary : $45 - $55