Manager

• Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations
• Provide scientific and compliance expertise to Global Patient Safety (GPS)
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Perform data analysis to evaluate safety signals and write up analysis results
• Author Safety Assessment Reports and other safety documents and regulatory responses
• Direct the planning, preparation, writing and review of safety portions of aggregate reports
• Prepare presentation of the Global Safety Team’s recommendations on safety issues
• Assist in the development of risk management strategy and activities
• Support activities related to new drug applications and other regulatory filings
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Provide support for clinical trials to review and provide input to study-related documents
• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV)

Global Safety Senior Manager

Global Manager – National Engagement Leads, Ultra Rare Diseases