Ensure completion of basic training in case handling. Begin and complete the process for competency sign off for A category cases.
Ensure that the case is QREd before closure in case the administrator is not signed off for A category cases.
Enter initial and follow-up information for individual adverse event case reports of low business risk onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instructions and associated SOPs and OPI to ensure consistency of case entry and high data quality standards.
Select the cases from the relevant mailbox (Clinical trial, Post Marketed) and enter the Patient Safety Administrator person?s name in relevant field in mailbox tracker. Document the Sapphire case ID in mailbox tracker.
Assign the case to a case owner as per Global Case Handling SOP.
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