A registered dentist with close to 8 years of experience in Pharmacovigilance, regulatory and aggregate report writing. I have worked with multinational IT enabled services organizations (Cognizant, Accenture, and Parexel) as a dedicated resource and SME for large Pharma clients. Have good experience in drafting and reviewing Aggregate/Safety reports (PSUR鈥檚 (40+),, PBRER (15+), PADER (100+), RMP, etc), Safety data exchange agreements (SDEA's), white papers, safety narratives, investigator brochures, study protocols, model informed consents, interim and final CSRs (clinical study reports), performing Signal detection activities and evaluation of health hazards, medical data review, litera.
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