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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. Join us.

Global Pharmacovigilance Senior Scientist - Nephrology/Inflammation

Live

What you will do

Let’s do this. Let’s change the world. The Global Pharmacovigilance Sr. Scientist works with the Therapeutic Safety Teams on aggregate safety assessment activities. This person will also provide scientific and compliance expertise as needed to GPS. Join the dynamic Nephrology/Inflammation therapeutic area within Global Patient Safety and serve safety experts for all Amgen products globally!

• Directs 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

Supports and provides oversight to staff with regards to safety in clinical trials:

• 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 the 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 presentations 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 content 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 responses 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 as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The passionate safety professional we seek is an impact player with these qualifications.

Basic qualifications

• Doctorate degree and 2 years of directly related experience, OR
• Master’s degree and 6 years of directly related experience, OR
• Bachelor’s degree and 8 years of directly related experience, OR
• Associate’s degree and 10 years of directly related experience, OR
• High school diploma / GED and 12 years of directly related experience

Preferred qualifications

• PharmD, NP, or PA with 2+ years of Global Pharmacovigilance Scientist expertise, or a BSN with 6+ years of Global Pharmacovigilance Scientist work experience
• Clinical experience is a plus
• Aggregate data analysis, interpretation, and synthesis in clinical development and post-market settings
• Signal detection, signal management, and safety governance
• Methods of qualitative and quantitative safety data analysis
• Processes and regulations for pharmacovigilance, risk management, and risk minimization
• Drug development and lifecycle management
• Argus
• MedDRA
• Product and disease state knowledge
• Sophisticated understanding of inter-relationships and interfaces across various pharmacovigilance and risk management processes, including reference safety information and product labeling
• Ability to analyze, interpret, and convey scientific data
• Application of statistical and epidemiological methods to pharmacovigilance

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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