Drug Safety Analyst

• Your responsibilities include the collection, evaluation, and reporting of adverse events and safety data, as well as contributing to the overall pharmacovigilance process

Key Responsibilities

• Adverse Event Reporting:Collect and review adverse event reports associated with pharmaceutical products, including drugs, biologics, and medical devices
• Ensure accurate and complete data entry and documentation
• Signal Detection:Identify potential safety signals by analyzing adverse event data, medical literature, and relevant information sources
• Evaluate and prioritize signals for further investigation
• Case Evaluation:Assess the causality and seriousness of adverse events and their relationship to the product
• Conduct medical review and determine appropriate action
• Regulatory Reporting:Prepare and submit expedited and periodic safety reports to regulatory authorities in compliance with established timelines and regulations
• Risk Assessment:Evaluate and communicate the risks and benefits of pharmaceutical products
• Collaborate with cross-functional teams to develop risk mitigation strategies
• Compliance:Ensure compliance with pharmacovigilance regulations, guidelines, and internal procedures
• Stay current with changes in regulatory requirements
• Database Management:Maintain and update safety databases with adverse event information
• Perform data reconciliation and quality checks
• Quality Control:Conduct quality control activities to ensure the accuracy and completeness of safety data
• Support audits and inspections related to pharmacovigilance
• Documentation:Maintain comprehensive and organized records, including case narratives, reports, and correspondence
• Adverse Event Training:Provide training and guidance to colleagues and staff regarding adverse event reporting and pharmacovigilance procedures