Sharath Kumar
Bengaluru
Summary
Experienced Argus Safety Techno-Functional Consultant with 7+ years of expertise in Drug Safety and Pharmacovigilance. Skilled in implementing PV safety systems, gathering requirements, performing configuration updates, PLSQL development, and Computer System Validation (CSV). Proven ability to deliver effective solutions that enhance compliance and streamline safety operations.
Overview
8
8
years of professional experience
Work History
Spec IT
Baxter
09.2024 - Current
- Transcribing technical details into requirements
- Act as a middle man between business and vendor IT team
- Ensure quality of internal PV and RA applications
- Develop and execute test scripts
Consultant
IQVIA
06.2021 - 08.2024
- Implementation of Argus Safety System for multiple top pharma clients
- E2B profile customization
- Configuring Argus Safety System based on client requirement(codelist, product, license, workflow, reporting rule etc.)
- Heading argus migration projects
- Participate in E2B Gateway testing activates for submission approvals from regulatory authority
- Develop PLSQL scripts for expedited reporting rule advance conditions.
- Troubleshooting production Issues
- Providing support during hypercare phase
- Conducting IMPA and providing KT and end user training on Argus
- Preparing and performing CRUT
- Develop and execution of IQ OQ PQ
Software Engineer
ArisGlobal
04.2017 - 06.2021
- Implemented Arisg for multiple pharma clients
- Deployment and maintenance of Arisg application in various environment(Development, Validation and Production)
- web server configurations(Apache tomcat)
- Loading and maintaining of MedDRA and WHO in database
- Developed PLSQL code in oracle and PostgreSQL
- Performed UAT
- Test case creation and execution
Education
Bachelor's in Engineering - Electronics And Communications Engineering
Academy For Technical And Management Excellance
Mysore01-2016
PUC - PCMB
GSI
Mysore, India01-2012
SSLC -
Anusha Vidya Shala
Mysore, India01-2010
Skills
- PL/SQL Development
- Argus System Proficiency
- Arisg Expertise
- Oracle Database Management
- PostgreSQL Database Management
- Apache Tomcat Configuration
Cricket, Badminton, Volleyball
Playing cricket, badminton, and volleyball with friends on weekends, promoting teamwork, fitness, and sportsmanship.
Timeline
Spec IT
Baxter
09.2024 - Current
Consultant
IQVIA
06.2021 - 08.2024
Software Engineer
ArisGlobal
04.2017 - 06.2021
Bachelor's in Engineering - Electronics And Communications Engineering
Academy For Technical And Management Excellance
PUC - PCMB
GSI
SSLC -
Anusha Vidya Shala
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