UAT SAFETY Jobs Opening in HCL Technologies Ltd at Hyderabad, Bengaluru, Chennai

• Bachelor’s 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