About our partner

• Write and project-manage the production of PSURS, NDA Periodic Reports, and IND Annual reports for assigned therapeutic area
• Conduct planning meetings (in person and teleconference) before each report and document the outcome
• Run queries from SCEPTRE and conduct a quality review of the output. Resolve findings from quality review with appropriate personnel/through appropriate channels
• Summarize the information on individual cases in aggregate and analyze it to provide conclusions regarding the adequacy of current Reference Safety Information
• Communicate with the team via phone, in person, and e-mail to coordinate and complete documents on time
• Import documents into Documentum system
• Work with document managers to publish and perform quality control on the final document
• Keep track of timelines in a formal tracking system
• Document the work carefully and keep organized appropriate files on the written reports
• Participate in expanded therapeutic area meetings
• Function as a resource to the department on aggregate reports
• Create an individual adverse event report: Conduct a medical review and assessment for seriousness, expectedness, and report determination per regulation requirement by the FDA and the European Authorities
• Review and edit case narratives
• Conduct physician-to-physician follow-up as needed
• Analyze causality and write pharmacovigilance comments and case summary for line listing of PSUR's
• Write/Analyze the U.S. Periodic Report (FDA) and PSUR (European Authority)
• Write and/or review a full report
• Create a narrative analysis summary
• Use pharmacovigilance evaluation and assessment
• Conduct a risk signal detection
• Label a change or modification proposal
• Provide Drug Safety Reporting Procedure and Process
• Design the work flow for adverse event data collection, report intake, triage, data entry, coding, verification and medical reviews
• Document the Standard Operation Procedure (SOP) for the above processes
• Create working documents
• Offer a Drug Safety Database
• Complete a literature search for spontaneous and/or study literature AE reports

YOUR BENEFITS:

• You will be provided professional and high quality services by a group of experienced industry drug safety physicians
• Your needs will be fulfilled in medical review due to a sudden case volume; surge or a temporary full-time staff shortage
• You will have a drug safety organization and process that is efficient and regulatory complaint
• You will have a recommendation for the best suitable drug safety database system for your organization
• You will eliminate the possibility of overlooking a case report in the literature