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DRUG SAFETY ASSOCIATEOn Assignment Clinical Research - Brisbane, CAUnder the leadership of the Manager of Drug Safety and Medical Information, the Drug Safety Associate will support the processes for the Drug Safety and Medical Information. Primary Responsibilities * Prioritize adverse events received in order to meet regulatory and global guidelines. Maintain regulatory compliance by ensuring that case entry is accurate, complete, and performed within specified timelines * Perform case entry in the global Safety Database system * Efficiently maintain source documents and case files associated with the registered adverse and serious adverse events * Track and enter dates of FDA submissions in the global Safety Database system * Use Database system queries and/or external spreadsheets to track department metrics and compile reports. * Track follow-up of open...originally from HH - More Tools...
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