Jayansh U.

WORK HISTORY

EDUCATION

ABOUT JAYANSH U.

I am a postgraduate in Biotechnology, eager to begin my professional journey in Pharmacovigilance. With a strong interest in drug safety and regulatory science, I am actively seeking an opportunity as a Drug Safety Associate and am available to join immediately.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, and complete case entry - Good knowledge to perform 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, 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 In addition, I have excellent attention to detail ability work effectively as part of a team, and once given the opportunity will be a valuable asset to the organization.