Veeva Safety QA / Validation Consultant

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 1. 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 1. 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