Drug Safety Associate manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products.
The DSA ensures timely submission of reports regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA and other drug regulatory agencies are responded to in a timely manner. The DSA will respond to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products; prepare periodic comprehensive written reviews of all assigned AEs; identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources; manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global AE database.
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