As a pharmaceutical physician I have over 8 years of experience in Pharmacovigilance & Drug Development, and 5.5 years of clinical experience (Total 13.5 years).
I have been involved in all aspects of clinical drug development with major contributions to the successful completion of registration and phase-IV trials.
Experience in providing clinical sections and review of regulatory documents such as Core Data Sheets (CDS), Patient Information Leaflets, Investigators Brochures, briefing books, safety updates (PSURs / PBRER, DSUR, RMPs, Annual Safety Reports), IND/NDA submissions documents, responses to Health Authorities questions, and expert statements (clinical overviews) to support ...
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