Eakta Sharma

WORK HISTORY

EDUCATION

ABOUT EAKTA SHARMA

Hi everyone i had total 2.5 years of experience and 1.5 years experience in pv.I had worked at indegene as a drug safety associate where i had the following ResponsibilitiesAssociate – Drug Safety Physician II March 2021 – Till Date· Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports.· Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement· Evaluate adverse event report for seriousness, listedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents are included and provide causality assessment.· Perform final check of the case and provide medical sign off on the case.· Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist.· Work and interact extensively with relevant stakeholders to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.· Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices.