Gaurav Maurya Email & Phone Number

I’m a postgraduate in Pharmacovigilance and Clinical Research. My greatest strength is "Attention to Detail" with hunger of learning and exploring new things. I am fully equipped with relevant skills for the job related to Pharmacovigilance and Clinical Research and ability to work independently but guided by documented procedures, with appropriate support. My professional skills in Pharmacovigilance are:• ICSR Mangement - Collecting the case from solicited and unsolicited Source and Processing them on the basis of validity criteria and seriousness criteria and providing them the triage followed by safety data base.• MedDRA Dictionary - Good knowledge to perform MedDRA coding for medical history, events, drugs /procedures/indications and laboratory tests in ICSR.• Safety Database -Hands on knowledge about safety database ICSR processing with defined WORKFLOW including duplicacy check.• Literature Monitoring - Experience of 300+ literature case monitoring related to a particular drug by the PubMed Source.• Aggregate Report - Knowledge of different aggregate report like PSUR, PBRER, PADER, DSUR with the reporting timeline in E.U, Japan, Australia, U.S.• ADR Reporting Form - Form filling of different Regulatory agencies like MedWatch, Blue card, Yellow card, CIOMS form, CDSCO/IPC form.• Exposure to PSMF, RMP Audits/Inspections along with Quality Management System.My Clinical Trial Skills Are -• Drug Development Process- Good knowledge of Drug Development Process starting from scratch to Post marketing of a drug including Process from Pre-clinical to Phase l-lV. • Clinical Trial Process - Well Acquainted with the process of various kind of Applications & it's approval Process including IND, NDA, ANDA with timelines and regulatory bodies (FDA, EMA, CDSCO)• Exposure to Various guideline related to Clinical Trial - ICH-GVP, 21CFR.• Additionally, thorough knowledge of Clinical Data Management, EDC, eTMF, CTMS.