Drug Safety

Case Processing: 75% of time Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness. Activities Include: • Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist) • Confirmation of Safety Coordinator case registry data • Database searches as necessary • Completion of literature searches as necessary • Completion of remaining case data entry, including narrative or auto-narrative • Completion of risk and quality (label, approval, manual coding & quality review steps) • Clarification of unclear or illegible information from the LSO or Call Centre • Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician • Completion of protocol request forms as necessary • Preparation of deviation memo as necessary • Request deletions as necessary • Single case unblinding Processes and Procedures: 5% of time Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include: • Standard Operating Procedures and Working Practices • Department guidance documents • MedDRA coding dictionary and MedDRA points to consider • Understand relevant safety implications regarding contracts with operating companies and/or marketing partners • Review and make suggestions for system and procedure enhancements 5% of time = Project Work, Audits, Inspections and other Ad-hoc