Global Pharmacovigilance (PV) Senior Scientist

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Pharmacovigilance (PV) Senior Scientist - US Remote

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What you will do

Let’s do this. Let’s change the world. In this vital role the Global PV Senior Scientist will work within the Therapeutic Safety Teams and will be responsible for safety deliverables for assigned Amgen products throughout product life-cycles.

Key responsibilities:

• Direct the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Supports and provides oversight to staff with regards to safety in clinical trials to:
  • 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
  • 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 to oversee 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 delegated by the QPPV …