Vyshnavi Kanamarlapudi

As a Associate in Configuration team,

• Hands-on Experience in Configured and managed over different kinds of Scenarios in Oracle Argus safety for Clinical Trails, IPU and AAxMP Studies, Code lists and Product families.
• Conducted training sessions over 20 users on Argus study configuration and Products Licenses Configuration.
• Experience in handling Business Configuration life cycle management including Studies, Product and Licenses Level.
• Hands on Experience in Configuring multiple families and Licenses with WHO Drug Dictionary and EDQM Insight in Argus Safety including Investigational and Marketed Licenses.
• Developed and updated SOPs for study configuration processes.
• Hands on Experience in handling Studies and Products Life Cycle Management.
• Hands on Experience in JIRA and Servicenow Platforms for Tickets Creation and Closing.
• Collaborated with Case Processing, Clinical and Safety teams to gather requirements and implement in configuration level.
• Solely responsible for managing and maintaining all monitoring reports.
• Hands on Experience on Tools (CAT, ICDS) which is collaborating with Argus.

• Good Experience in Pharmacovigilance, Oracle

Argus Domain and HiLiT Application.

• Good knowledge and experience on SQL Joins, Functions, RDBMS.
• Having knowledge on 21 cfr part 11, US FDA Rules and Drug Development Process.
• Strong domain knowledge in the field of Pharmacovigilance.
• Experience in designing test scripts, Dry runs and Formal Executions based on risk category of user requirement.

Project Work

Otsuka ( Feb'22 - Dec'22 ):

As a Associate in PVBI ( Pharmacovigilance Business Intelligence ) reporting team,

• Hands on experience in generation of scheduling and Advanced condition CIOMS reports.
• Good experience in generating Adhoc reports based on User request form.
• Knowledge on ICSR Case Processing and Custom reports development through Validation life cycle.
• Experience on performing OQ, PQ scripts authoring.
• Hands on experience in Dry runs and Formal executions,Traceability matrices.
• Good knowledge on GxP, GAMP5 category. Worked on AGILE SDLC methodology for project orientation.

HiLiT Core GA 2.0 ( Jan'22 - Mar'23 ) : As a Associate in Testing team,

• Worked on creating test scenarios and writing test cases, Traceability Matrices.
• Experience on Formal Executions and Dr run testing of HiLiT Application.
• Good knowledge on HiLiT Application.