Subrahmanyam Datar

Working as a Project Maganer, Pharmacovigilance Operations with well over 10 years of experience in the field of Pharmacovigilance. Strong background in US FDA, Health Canada, EMA, MHRA, and TGA drug safety guidelines. Knowledge of ICH, GCP and GVP guidelines. Experience in ICSR triage, data entry, follow-up, MedDRA coding, quality review/assurance, ICSR submissions and relational databases (Argus, EVWEB, BaseCon, RAVE). Experience in leading and management of pharmacovigilance audit/inspection readiness. Experience in authoring, reviewing and management of pharmacovigilance specific controlled documents such as SOPs, work instructions, plans, guidelines etc. for multiple clients. Fluent written and oral communication skills. Excellent customer relations and account management. Good organizational and analytical skills for the management of multiple concurrent projects; ability to handle multiple tasks, and be detailed oriented. Cross-Functional Team Player

Working as a Project Maganer, Pharmacovigilance Operations with well over 9 years of experience in the field of Pharmacovigilance. Strong background in US FDA, Health Canada, EMA, MHRA, and TGA drug safety guidelines. Knowledge of ICH, GCP and GVP guidelines. Experience in ICSR triage, data entry, follow-up, MedDRA coding, quality review/assurance, ICSR submissions and relational databases (Argus, EVWEB, BaseCon, RAVE). Experience in leading and management of pharmacovigilance audit/inspection readiness. Experience in authoring, reviewing and management of pharmacovigilance specific controlled documents such as SOPs, work instructions, plans, guidelines etc. for multiple clients. Fluent written and oral communication skills. Excellent customer relations and account management. Good organizational and analytical skills for the management of multiple concurrent projects; ability to handle multiple tasks, and be detailed oriented. Cross-Functional Team Player

Masters in Pharmacognosy