Global Safety Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Global Safety Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. The Global Safety Manager will also provide scientific and compliance expertise as needed to Global Patient Safety (GSP).

Responsibilities:

• Contributes to the planning, preparation, writing and review of portions of aggregate reports
• Works with affiliates and other internal Amgen partners regarding deliverables
• Review of 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 of AEs/SAEs from clinical trials as needed
• 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
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body

Assist GSO in the development of risk management strategy and activities:

• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs with aspects of risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings
• Assist GSO in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings

Inspection Readiness:

• Undertake activities …