Komal Shinde

Background

About Komal Shinde

Pharmacovigilance Professional with 5 years+ of experience in capturing and assessing adverse event reports associated with client products on a worldwide basis on the client's drug safety database, by international and local regulatory requirements. Strong knowledge of MedDRA, WHO Drug Dictionary, and coding practices. Thorough understanding of adverse event reporting and safety databases. Managed Individual Case Safety Reports of all case types (serious and non-serious cases) from spontaneous, solicited and us-solicited programs, clinical trial sites, literature, Digital media, Health authority & E2B cases, which included: Triage of Confidential to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities. Good knowledge of the quality and confidentiality of patient data and the process involved in processing it to make it presentable per regulatory requirements.