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