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– Confirm that the information in the Global Safety Database is accurate and consistent with the Source Documents
– Confirm that the information has been data entered in accordance with applicable Guidelines and SOPs
– Perform medical coding for each ICSR in accordance with Guidelines and SOPs using MedDRA
– Confirm the accuracy of terminology and coding and manually recode any errors or inconsistencies as needed per Guidelines and SOPs
– Conduct the seriousness assessment and global expectedness (listedness) assessment and conduct a Local Assessment for cases that qualify for reporting to regulatory agencies in the US and Canada;
– Prepare a Case narrative for each Case, which reflects the safety data. The Case narrative should be a concise summary of the facts of the case, and the format should follow applicable Guidelines and SOPs
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