Receives reportable event information [ Serious Adverse Events (SAE) ] creates, reviews and manages case reports for these events. Submit to regulatory group to meet reporting timeframes and ensure compliance with regulations. Supports the clinical team in the medical review of reportable event data, ensures that all information needed to support a sound medical case is obtained. Generates safety queries to the study sites to resolve gaps and discrepancies in the data related to reportable events. As a member of the Medical Monitoring Team, provides individual case report input during Medical Monitoring Team review of cumulative/aggregate review of Serious adverse event data. Reconciles critical data points between clinical and safety database regarding reportable events and ensures inclusion of the quality case attributes.