Perform Case Processing, generating case receipt #, Case Triage and process adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within the FDA required timelines.

Support the oversight of PV Vendors; including and not limited to oversight of reconciliations, ICSR case quality metrics, and outsourced case processing activities.Responsible for the monitoring on a daily basis of the PV mailboxes, fax machines share points/portals and acknowledging receipt of safety case reports.Responsible for Book-in, duplicate check and accurate full Data Entry of safety case reports into safety database in a timely manner and also Generates draft case narrative as assigned by Client PV Management. Produces assigned work at high quality and according to timelines. Assists in the preparation and quality control of periodic safety reports, as assigned by Client PV Management and in the timely distribution of safety reports to Health Authorities, clients and client partners, in the appropriate format. Assist in sending and tracking follow up queries for safety case reports in a timely manner. Ensures filing of safety case reports and other project-related documents, as required. Assists in the timely and accurate completion of reconciliation activities either electronically, manually, Audit readiness. Assists in the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature, as assigned by Client PV Management. Triage, MedDRA coding of AE, Verification of IRD Attends Client PV Department meetings.

Data entry of adverse event reports. Triaged case processing. Ensured all safety regulatory documents are processed and submitted. Submit IND reports, DSUR and PBSURs.