Nikhil Anbhule

WORK HISTORY

EDUCATION

ABOUT NIKHIL ANBHULE

Performing Case processing, narrative writing, MedDRA coding, causality assessment, labeling, event mapping, and ranking in the database.(LSMV, ARISg, Veeva vault safety, Argus)*Trage of incoming cases to prioritization of daily workflow management. End to End case processing intake to case Approval state.* Updated and entered appropriate and precise Data in to clinical Database And ensured Data was captured according to departmental SOPs. Worked on Arisg and Veeva Vault drug safety database.* Ensured accuracy of coding, which includes the selecting appropriate Event Terms im MedDRA and worked closely with coding Department.*Worte Narratives summarizing event in chronological format according to regulatory SOPs and did quality check of case processed before reporting to regulatory Authority.*Administered of entry and revision of Applicable information in to the global safety Databases for initial or follow-up report received via pepar Fax. or Email.*Ensured regulatory compliance for individual Expedited cases and case reports submission to Health Authority Or other receivers as appropriate.*Maintained and excellent knowledge of case processing convention and guidelines, Clint\'s Procedure and international drug safety regulations.* Participate in cross functional training to ensure adherence organizational polices and procedures.*Perform Quality Review and checking cases of discrepancy any errors related to case processing and PV convention related. QC cases procesed by The MSA.* Providing the support to the team members for any case processing queries and Allocation of cases and tracking Due casescases.*worked in Qualify check tool team along with case processing. reviewed cases of offline E2B check and assigned correction to associate across all the site.*Ensured incoming Adverse events reports are processed accurately. provided internal feedback and training sessions to maintain quality and compliance to regulatory authority.