Manager

• Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations
• Provide scientific and compliance expertise as needed to GPS
• Contribute to planning, preparation, writing and review of non-medical portions of aggregate reports
• Work with affiliates and internal Amgen partners regarding deliverables
• Review AE/SAEs from clinical trials as needed
• Review and provide input on study protocols, statistical analysis plans and other clinical study-related documents
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Attend study team meetings as requested
• Conduct signal detection, evaluation, and management
• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
• Prepare safety assessment reports and other safety documents and regulatory responses
• Search and review adverse event data, literature, and other safety-relevant data for signal detection
• Participate in Safety Governance per Amgen processes
• Prepare presentations of Global Safety Team recommendations on safety issues
• Assist GSOs and Senior Scientists in development of risk management strategy and activities
• Provide content for risk management plans and update regional risk management plans
• Assist coordination and tracking of risk minimization activities
• Prepare responses to regulatory inquiries related to risk management plans under GSO guidance
• Support activities related to new drug applications and other regulatory filings
• Undertake activities delegated by the QPPV and maintain inspection readiness
• Act as point of contact for Health Authority Inspections and Internal Process Audits within remit

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