Arpan Pachauri

Writing and facilitating the authoring of various regulatory documents.

Clinical trials transparency- Disclosure of Clinical trial protocols and results Regulatory writing- Writing various regulatory documents: CSRs, regulatory responses, NDA ARs, etc. Quality review of Clinical trial protocols (and amendments) and CSRs

Identifying safety information in the published biomedical literature. Writing safety summaries of published medical literature articles to be published in Reactions Weekly (Springer). Writing individual patient narratives and creating E2B for expedite reporting of published.

Individual case safety report analyses and data entry in PV safety database- Argus by Oracle. Coding of AEs using MedDRA, narrative writing, coding of suspect drug and other medications as per WHO drug dictionary

Worked as a PV associate- collection and analysis of the first hand experience with the pharma products (safety issues and product complaints)