Drug Safety

Job description

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 A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.