Zachariah Thomas

#Pharmacovigilance systems support specialist #Regulatory system support specialist #CSV Specialist #Software Tester

Role
Regulatory System Specialist at GSK
Location
Bengaluru, IN
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Zachariah Thomas

A dynamic professional with 4 years of experience, having unique combination of business experience, technical and excellent communication skill, bringing together the ability to combine business development with technical applications. • Managing Computer System Validation for pharmacovigilance software systems with experience in writing URS, PQ, Traceability matrix, Configuration Specification and Configuration Verification, evidence capturing and Release Notes as applicable. • End to end testing of Total Safety applications as part of SDLC. • Experience in manual testing and testing using HPQC - ALM system. • A good working knowledge in GVP Module 6, FDA 21 CFR Part 11, GAMP 5. • Handling of tickets (Incidents or Tasks)received via ServiceNow. • A part of migartion, Implementation, goliv and further hypercare support. • Experience with different safety databases like ArisG 7, LSMV, SafetyEasy (AB Cube), Veeva vault safety. • ICSR handling and processing including intake and triage.

Experience

  1. Regulatory System Specialist

    GSK

    Jul 2024 — Present · Bengaluru, IN

Education

  • Annamalai University

    Doctor of Pharmacy - PharmD

    2009 — 2015

  • Jai rani public school

    Doctor of Pharmacy - PharmD

    2009 — 2015

  • Annamalai University

    Doctor of Pharmacy - PharmD

    2009 — 2015

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Zachariah Thomas — Regulatory System Specialist at GSK in Bengaluru, IN | Unifers