UAT Safety Jobs Opening in For a Client of TeamLease Digital at Hyderabad, Chennai, Bengaluru
FEATURED JOBUAT Safety
Job Description
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
