Associate II (Patient Safety Solutions)

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial, including triage of incoming cases, duplicate checks, and single case creation in the Oracle Argus safety database. Responsible for performing validity, seriousness, expectedness/labeledness/listedness and determine causality using the WHO -UMC system. Perform medical adjudication of incoming cases for the event seriousness in coordination with the medical review team. Ensure accurate data entry, coding, and identification of clinically significant information. Maintain a comprehensive understanding of safety management SOPs. You will support root cause analysis and participate in audits and inspections as needed.