Kiran Surendra

Experience

• 

  Bharat Electronics

  Apr 2002 - May 2002

  Project Trainee

  Completed my internship on Voice Over Network using VC++

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  ArisGlobal Software Pvt. Ltd., Bangalore, India

  Mar 2004 - Apr 2008

  Principal Software Engineer

  Worked on various projects and developed a strong understanding of the pharmaceutical domain as a Developer, Tester and Technical Lead.Played a key role in several projects (ARISg, agXchange, Universal Connector and ESM) that included requirement analysis, design, development, testing, and implementing pharmaceutical clinical and regulatory applications using various development tools.Key clients: Pfizer Japan, Merck, Roche

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  Aris Global LLC

  May 2008 - Jan 2016

  Associate Manager

  - Implementation of Total Safety Solution - Gathering business requirements, translate business objectives into clear functional and technical requirements.- Preparing, reviewing and executing IQ and OQ scriptWorked on the following products:1. Total Safety Solution (ARISg, agXchange, agSignals, agEncoder and ESM)2. Bizconnect and Bizlink (Setup and Configuration)Worked for the following clients:1. Celgene Corporation2. Takeda Pharmaceuticals3. Hoffmann La Roche4. Forest Labs5. OSI6. United Therapeutics7. Abbott Laboratories Show less

• 

  Regeneron Pharmaceuticals, Inc.

  Feb 2016 - Dec 2019

  Manager

  - Overseeing external managed services team (onshore and offshore) for resolution of incidents, issues and queries- Responsible for maintaining safety database (Argus, IRT, Axway) and ensuring day-to-day run operational support to meet business expectations and compliance requirements- Perform periodic MedDRA , IME and WHO drug dictionary upgrades- Managed successful upgrade of Argus and Axway in accordance with the validation process like creating change control, reviewing IQ, OPQ, FRS and RTM- Gathered requirements and developed adhoc listings and periodic reports (PAER, DSUR) using IBM Cognos (PVQ)- Provided support for regulatory and partner inspections- Developed custom solution using PL/SQL to implement site security in Argus Show less

• 

  Gilead Sciences

  Dec 2019 - now

  - Overseeing external managed services team for resolution of incidents, issues and queries. Responsible for developing and presenting KPI metrics and project status to the Senior Leadership team.- Performing safety database administrator functionalities like maintaining configuration changes, configuring reporting rules, providing user access, role configuration, ICSR checks and reporting/distribution rules in Argus.- Involved in data migration and divestiture migration projects in SME role. Show less

  • Associate Director

    Jan 2023 - now

  • Senior Manager

    Dec 2019 - Dec 2022