Schedule: Full-time
• 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
Bachelors Degree in Life Sciences or Healthcare degree required, e.g. Registered Nurse, Pharmacist, Physician;
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