Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
• 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 safety databases
• 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 with timely and accurate expedited safety reporting
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety
• Perform drug coding and maintain drug dictionaries 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
• Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
• Maintain compliance with SOPs, WIs, drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
• Foster professional working relationships with project team members
• Participate in audits
• Apply safety reporting regulatory intelligence to safety reporting activities

Safety Specialist jobs in India

Safety & PV Specialist – Future Roles