Global Safety Senior Manager – Hematology Oncology
Amgen
Salary
💰 $122,105 - $145,799 per year
Job Level
Mid-LevelSenior
About the role
- 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 the planning, preparation, writing and review of non-medical portions of aggregate reports
- Work with affiliates and other internal Amgen partners regarding deliverables
- Review AE/SAEs from clinical trials as needed
- Review and provide input and support 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 or needed
- Conduct signal detection, evaluation, and management; perform data analysis and write up analysis results
- Prepare safety assessment reports and other safety documents and regulatory responses
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Participate in Safety Governance per Amgen processes and prepare presentations of the Global Safety Team’s recommendations
- Assist GSOs and other Senior Scientists in development of risk management strategy and activities; update regional risk management plans and coordinate risk minimization activities
- Prepare responses to regulatory inquiries related to risk management plans and support activities related to new drug applications and regulatory filings
- Undertake activities delegated by the QPPV and maintain a state of inspection readiness; act as point of contact for Health Authority Inspections and Internal Process Audits within remit of role and responsibility
Requirements
- Doctorate degree OR Master’s degree and 3 years of Global Patient Safety experience OR Bachelor’s degree and 5 years of Global Patient Safety experience
- BS or BA in Life Science with a MS and 3 years of Global Patient Safety experience (preferred)
- Clinical/medical research experience (preferred)
- Experience in a biotech/pharmaceutical setting (preferred)
