Drug Safety Public Health Specialist - I - (Foster City, CA)

Description: Operations Sets work priorities and direction with input from Manager. Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products. Interpret case-related info including medical conditions, lab results and procedures, as well as compile complete narrative summaries. Review, enter, and verify follow-up info for cases and make accurate determination of significant info Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent info for incorporations into the case narrative Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries. Have basic current knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.