Primary Function:
The safety physician (associated manager / manager / senior manager) performs the medical assessment activities related to drug safety pharmacovigilance for the assigned products. The safety physician proactively evaluates safety information from individual cases and cumulative data, identifies and analyzes potential signals, and communicates data-driven conclusions to internal and external stakeholders.
Major Responsibilities and Duties:
• Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Working Instructions, the Argus User Reference Guide and case processing/coding conventions.
• Maintain and support the timely submission of expedited reports.
• Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
• Identify and evaluate safety signals based on individual cases and cumulative data assessment. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
• Partner with other functional groups to monitor the safety profile of assigned products.
• Actively participate in risk management activities for assigned products. Perform product safety reviews as appropriate.
• Provide medical safety input as appropriate to clinical operation teams/ medical teams and other relevant function teams regarding expectedness/listedness/labeledness, causality, and data reconciliation.
• As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.
• Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements.
• Provide timely input into product related milestones.
• Provide medical input, review and analysis of Development Safety Update Reports, Periodic Safety Update Reports, Risk Management/ Control Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.
• Provide medical advice and insights to PV operation team to improve the quality, consistency, accuracy, and clinical relevance of safety reports.
• Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues.
• Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
• Proactively communicate with and engage PV operations and key stakeholders (e.g., Clinical Operation Teams, Medical, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.
• As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with company strategic objectives.
• Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio.
• Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Working Instructions, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.
• Utilize the corporate performance management process to manage goal setting and individual development.
• Contribute to the mentoring and on-boarding of new safety colleagues.
