Pranchal Garg Email & Phone Number

As a Post Graduate in Pharmacology. I am passionate about drug safety to ensure strict patient safety compliance. I am fully equipped with relevant skills for the job of Drug Safety Associate and the ability to work independently but guided by documented procedures, with appropriate support. My professional skills in Pharmacovigilance are: - Performing the review and evaluations of ICSR information for validity, seriousness, expectedness and causality assessment following standard Pharmacovigilance procedures and guidelines- Hands-on experience in writing safety narratives for ICSRs from different sources like Spontaneous, Literature etc. - Hands-on experience in processing 60+ ICSRs meeting the quality standards and timelines- Hands-on knowledge about safety database ICSR processing with defined WORKFLOW including Duplicacy check, case Book-In, complete case entry - Good knowledge of performing MedDRA coding for medical history, events, drugs /procedures/indications and laboratory tests in ICSRs- Exposure to Global Pharmacovigilance activities and standards including ICH, GVP, 21 CFR, CIOMS etc. for developmental and/or marketed products.- Exposure to aggregate reporting in Pharmacovigilance including PSUR/PBRER, PADER, and DSUR including processes, timelines and standards as per EU, US etc. - Exposure to signal generation and safety analysis activities- Exposure to Audits/Inspections along with Quality Management System - Hands-on experience of in-vivo and in-vitro studies. In addition, I have excellent attention to detail ability to work effectively as part of a team and once given the opportunity will be a valuable asset to the organization.