UAT Tester - Pharma Safety Applications

Job Location - Chennai & Hyderabad

Keywords Safety systems, Argus, ArisG, Veeva Vault Safety, Reporting tools, Pharmacovigilance

Roles and Responsibilities

Must Have

• Bachelors or Master’s degree in Life Sciences, Pharmacy, Computer Science, or related field.
• 4–8 years of experience in IT testing/validation, with at least 2–4 years in Pharma Safety/Pharmacovigilance systems.
• Strong understanding of drug safety processes (case processing, MedDRA/WHO Drug coding, signal detection, expedited and periodic reporting).
• Collaborate with pharmacovigilance, clinical safety, regulatory, and IT teams to understand business and compliance requirements.
• Hands-on experience with Safety applications (e.g., Oracle Argus, ArisG, Veeva Safety, or similar).
• Prepare UAT strategy, test plans, test cases, and traceability matrix aligned with URS (User Requirement Specifications).
• Execute UAT test scripts, record results, log defects, and track resolution with IT/vendors.
• Validate workflows related to case intake, triage, medical review, reporting, E2B (R2/R3) submissions, and signal detection.
• Perform regression testing of safety system upgrades, patches, and integrations with safety/ Pharmacovigilance systems (Argus, ArisG, Vault safety, etc.).
• Ensure compliance with 21 CFR Part 11, GAMP 5, GDPR, and global pharmacovigilance requirements.
• Support end-user training, readiness checks, and post-UAT sign-off.
• Document deviations, manage defect triage calls, and ensure timely closure.
• Prepare UAT summary reports and contribute to release readiness assessments.
• Support audits and inspections by providing UAT evidence and documentation.
• Contribute to continuous improvement of UAT processes and test automation where applicable.

Good to Have (secondary skills)

• Knowledge of UAT methodology, SDLC, and CSV (Computer System Validation) frameworks.
• Familiarity with global pharmacovigilance regulations (ICH E2B, EMA GVP, FDA, MHRA, PMDA).
• Proficiency in defect management tools (e.g., JIRA, HP ALM, Veeva QMS).
• Strong analytical, documentation, and communication skills.
• Ability to work cross-functionally with PV operations, QA, IT, and vendors.

Communication

• Immaculate communication and handles multiple clients/ projects
• Works in Consulting capacity

Best Regards,

Sanjay Kumar