Venkat Chowdary Somepalli
Validation Consultant @ERGOMED
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WORK HISTORY
Validation Consultant @ERGOMED
Andhra Pradesh, IN
Working as a validation analyst as per GAMP 5 methodologies: developing verification/validation related documents including but not limited to validation plans, OQ/PQ documents, traceability matrices, and managingthe execution of user acceptance testing; authoring and execution of OQs and PQs for ARISg, OST, and LSMV upgrades; performing verification of medical devices module of ARISg and LSMV; and performing functional testing, integration testing, system testing, smoke testing and regression testing.As part of safety database implementation projects, worked as a validation analyst for BRIDGE NEOS implementations, upgrades and patches; supporting testing & validation activities; performing validation activities such as authoring/executing IQ/OQ/PQ scripts.Understanding the requirements and Active involvement in business meetings to define requirements for UAT.Worked on different modules in LSMV like Case intake, Case processing and Submissions and other PV system like AERO.UAT testing and drafting and performing dry run for the UAT scripts.Supporting the Automation of the UAT test scripts for TOSCA Automation.Performing dry runs of queries, reporting issues, and coordinating with cross functional team for bug closure.
ABOUT VENKAT CHOWDARY SOMEPALLI
A pharmaceutical professional with above 9 years of experience in Pharmacovigilance operations and Validation activities in pharmacovigilance products such as ARISg, IRT, OST, LSMV, BRIDGE NEOS and testing activities forsafety database implementations and upgrades (LSMV), software implementations with proficiency in Case Processing, Regulatory Reporting, Quality/Compliance Management and Regulatory reporting/submission forClinical and Post Marketing projects. Expertise in EudraVigilance, Webtrader and Oracle Argus Safety Databases. Recognized consistently for performanceexcellence and contributions to success in industry. Substantial knowledge of Pharmacovigilance guidelines, GCP and GVP guidelines and MedDRA. Have thorough knowledge in clinical trials, investigator - sponsored studies, and related activities.Specialties:End-to-End Case Processing (Clinical trails) Narrative writingCapturing of Adverse Event (AE) through various sources and assessing of expectedness/listednessCategorizing of cases on basis of seriousness criteria Searching of weekly literature Planning of Risk ManagementInitiating and handling case suppression/nullificationGlobal Pharmacovigilance Regulatory Reporting.
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