Jitendra Suthar

I have 10.5 years of experience in drugs, vaccine and I am well-versed with all regulatory guidelines. I have specialized in drug safety i.e., pharmacovigilance, and writing aggregate reports such as PBRER, PSUR, and PADER and signal management activity. I have hands-on experience in the ARGUS database, Veeva Vault safety database, ARISg, AWARE database, literature review, MedDRA coding, WHO DD, individual case safety report (ICSR), medical narrative writing, including spontaneous reports, post-marketing surveillance reports, and literature reports and supported the quality team for late case analysis and writing CAPA, supported during internal and external audits. Intake, triaging, assessing, data entry (processing), and Quality review of AEs and product complaints in the global safety electronic database for drugs. Conduct a literature search and review to identify ICSR and summarize the article for aggregate reports. I have performed medical reviews of the document with respect to scientific accuracy, acted as subject matter expert for safety inputs and worked with cross-functional teams to ensure the timely delivery of regulatory safety reports. Moreover, I have hands-on experience in the safety database for ICSR processing, quality, and medical review; and support in the development of benefit/risk assessment and risk management strategies.

I have 10.5 years of experience in drugs, vaccine and I am well-versed with all regulatory guidelines. I have specialized in drug safety i.e., pharmacovigilance, and writing aggregate reports such as PBRER, PSUR, and PADER and signal management activity. I have hands-on experience in the ARGUS database, Veeva Vault safety database, ARISg, AWARE database, literature review, MedDRA coding, WHO DD, individual case safety report (ICSR), medical narrative writing, including spontaneous reports, post-marketing surveillance reports, and literature reports and supported the quality team for late case analysis and writing CAPA, supported during internal and external audits. Intake, triaging, assessing, data entry (processing), and Quality review of AEs and product complaints in the global safety electronic database for drugs. Conduct a literature search and review to identify ICSR and summarize the article for aggregate reports. I have performed medical reviews of the document with respect to scientific accuracy, acted as subject matter expert for safety inputs, and worked with cross-functional teams to ensure the timely delivery of regulatory safety reports. Moreover, I have hands-on experience in the safety database for ICSR processing, quality, and medical review; and support in the development of benefit/risk assessment and risk management strategies.

I have completed my MBBS (Bachelor of Medicine, Bachelor of Surgery) from MGM's College, Navi Mumbai.