Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR
• Assist in processing ICSRs according to SOPs and project/program-specific safety plans
• Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
• Enter data into the safety database
• Code events, medical history, concomitant medications, tests, indications, products, and substances
• Compile complete narrative summaries
• Identify information to query and follow up until queries are satisfactorily resolved
• Assist with timely, consistent, and accurate expedited safety reporting
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety
• Validate and submit xEVMPD product records
• Perform activities related to SPOR / IDMP
• Conduct quality review of ICSRs
• Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
• Maintain compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
• Foster professional working relationships with internal and external project team members
• Participate in audits as required
• Apply Syneos Health regulatory intelligence to safety reporting activities

Safety specialist processing pharmacovigilance cases for Syneos Health’s biopharmaceutical clients

Safety Specialist I

Safety Specialist processing individual case safety reports and regulatory submissions for Syneos Health’s biopharmaceutical clients. Supporting clinical-trial and post-marketing pharmacovigilance activities across Mexico and Argentina.

• process and review safety documents only
• process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents
• ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
• communicate document inquiries with responsible users as needed
• liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues

TMF Specialist processing safety documents for clinical trials at Syneos Health

TMF Specialist, Safety Processing – Min 2 Years of Experience in Central File Management

TMF Specialist processing safety documents for clinical trials at Syneos Health. Ensuring TMF quality and collaborating with global teams for document management.

Safety Specialist jobs in Argentina

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Safety Specialist I

TMF Specialist, Safety Processing – Min 2 Years of Experience in Central File Management