Kumaraguru Anbalagan
Senior Manager Pharmacovigilance @ICON plc
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WORK HISTORY
Senior Manager Pharmacovigilance @ICON plc
Chennai, IN
Managing & Maintaining the Global Argus Safety Database, Vendor Management, Process improvement using Technology
EDUCATION
Vel's College of Pharmacy, Chennai
Bachelor of Pharmacy (B.Pharm.), Pharmacy
J.S.S. College of Pharmacy
M.Pharmacy, Clinical Pharmacy
Vel's Institute of Science, Technoloyg and Advanced Studies, Chennai
Doctor of Philosophy - PhD, Pharmacy
ABOUT KUMARAGURU ANBALAGAN
Overall 19+ years experience in Pharmaceutical Industry including 2 years in Pharmaceutical Marketing and 17+ years in Pharmacovigilance and Drug Safety- Certified Drug Safety Associated by IAOCR- Train the Trainer and Subject Matter Expert (SME) for ARISg & Argus Safety Database- Developing User Acceptance Testing (UAT) Documents [User Requirements Specification (URS), Functional Requirements Specifications (FRS)] & Test Scripts for Argus 8.1.2.4 Implementation in a Phased manner- Acting Business & System Analyst for the Implementation of Argus 8 (Workflow, Regulatory Reporting Rules, Prioritization, Case Validation, Code lists, Reporting destination, Axway set-up & testing requirements, issue solving while Import & Export of data in and out of Argus Database)- Actively participated in Oracle Business & Technical workshop- Configuring New Argus Tenants (Study, Products, Licenses, Codelists) based on the Protocol (Study/Device/Vaccine), Listings (CTPR/Reconciliation) & E2B submission (EVCTM/EVPM) requirements- UAT document preparation and execution of UAT in Argus New Tenants to release the Safety Database for Live Case Entry- Aggregate & Periodic report generation for different projects from ARISg & Argus- Broad Technical & Configuration knowledge in Data Migration (electronic) of ICSRs from ARISg to Argus & Argus to Argus- Thorough knowledge & logic in E2B XML based migration to Argus and developing UAT documents of it- Thorough knowledge on ICH E2B fields according to GVP and ICH E2B (R2) & (R3) guidelines and Updation of SSP, ARISg & Argus General Data Entry Convention- Writing, evaluating Working Procedures (WPs) for end to end case processing- E2B Submission of ICSRs via AgXchange & Argus Interchange to EMA, BfArM, MHRA & other E-Reporting Member States and Ethics Committees- EVWEB case processing and submission to electronically acceptable EU countries- Test case manual generation for ARISg & Argus- Test case data entry and Reporting for gateway set-up in ARISg & ArgusTools Handled:ARISgArgus SafetyIRMS Lorenz docuBridgeAgXchangeEVWEBOCRDCRAVEMEDIDATAINFORM
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