Safety Processing Expert @ Novartis B9

Job Description: 
 Facilitates safety monitoring by optimizing scientific quality documentation and data entry of Safety case reports for Novartis drugs. Responsible for the receipt, tracking, acknowledging and initialization of single case drug safety reports into the safety database. Responsible for accurate data entry and coding of adverse event reports and evaluation of non-expeditable reports within well defines timeframes, in compliance with DS&E business rules, standard operating procedures and regulatory requirements. Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file, acknowledge and initialize received drug safety reports in the DS&E tracking tool and/or safety database. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality. Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy. Use medical dictionaries and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case. Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed. Alert manager to potential safety signals based on incoming case reports. Work with Novartis country safety departments, License partners, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and data based. Assist with related administrative and procedural activities as required or requested. Support DS&E Projects or database validation activities as required.

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