Work & Experience
Manage expedited ICSR cases and all adverse event reports in accordance to associated SOPs, OPIs and global and regional procedures to ensure consistency of case entry and high data quality standards. Review and assess all source documents, and compile data in an adverse event report and entry onto adverse event safety database (Sapphire). Proper narrative writing and MedDRA coding of events. Ensure case receives proper medical review. Quality Review Evaluation of cases. Generating and responding to queries Perform all activities within the required timeframes to ensure regulatory compliance and support a performance driven culture. Exchange of documents and notification to Licensing Partners/other company as per PV agreements. Performing significant corrections as per guidelines set by the clients. AE / SAEs extraction and Coding of AE / SAEs in MedDRA and Drug dictionary Writing safety narratives, including summarization of the essential details of the case on the basis of source document or data receive on follow up.