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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 Safety Senior Medical Scientist – Global Safety Physician

Live

What you will do

Amgen is seeking a Global Safety Physician at its main headquarters in Thousand Oaks, CA to join the GPS-TAS (Global Patient Safety – Therapeutic Areas) organization and will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products. The Global Safety Physician will report to either a Global Safety Officer or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products as designated by GSO or TAH (therapeutic area head). The Global Safety Officer may delegate to the Global Safety Physician.

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global Safety Physician is responsible for the following:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products
• Supports and provides oversight with regards to safety in clinical trials to
• Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies.
• Support activities related to new drug applications and other regulatory filings
• Perform Signal detection, evaluation, and management
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and pharmacovigilance scientist
• Prepare presentations to the Global Safety Team on safety issues
• Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities

Win

What we expect of you

Basic Qualifications

MD or equivalent degree from an accredited medical school

Preferred Qualifications

• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Clinical/medical research experience
• Product safety in the bio/pharmaceutical industry
• Inflammation and nephrology knowledge

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we 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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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.