Safety Specialist

• Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.
• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings
• Participates in project specific teleconferences/meetings as required
• Other duties assigned by management

Safety Specialist II

• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process

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Safety Specialist II

Safety Specialist II