Safety Specialist

• Lead and oversee preparation of complex safety reports
• Receive, prepare, and submit safety reports to applicable parties
• Ensure reports comply with regulatory timelines, country legislation, and agreed processes
• Monitor safety reporting compliance regularly
• Lead large-scale projects and ensure timely submission of safety reports
• Provide input and feedback for program and departmental procedural documents
• Share ideas and participate in implementing improvements
• Liaise with relevant departments and attend required meetings
• Provide guidance and feedback to team members
• Mentor new starters and assist lower-level colleagues
• Produce metrics and participate in financial projects
• Work in office, laboratory, and/or clinical environments with potential exposure to biological fluids and infectious organisms
• Use required personal protective equipment

Senior Safety Reporting Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
• 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, and tests
• Compile complete narrative summaries
• Identify information to be queried and follow up until queries are satisfactorily resolved
• Assist in generating timely, consistent, and accurate expedited reports in accordance with regulatory requirements
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety, drug coding, drug dictionary maintenance, and MedDRA coding
• Validate and submit xEVMPD product records, including coding indication terms using MedDRA
• Manually recode un-recoded product and substance terms from ICSRs
• Identify and manage duplicate ICSRs
• Perform activities related to SPOR / IDMP
• Conduct quality review of ICSRs
• Ensure relevant documents are submitted to the TMF and Pharmacovigilance System Master File as appropriate
• Maintain compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process
• Foster professional working relationships with project team members
• Participate in audits as required
• Apply Syneos Health regulatory intelligence to safety reporting activities

Safety Specialist jobs in Brazil

Senior Safety Reporting Specialist

Safety & PV Specialist I