Job Description

Career Category Safety



HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you\xe2\x80\x99re part of something bigger, it\xe2\x80\x99s because you are. At Amgen, our shared mission\xe2\x80\x94to serve patients\xe2\x80\x94drives all that we do. It is key to our becoming one of the world\xe2\x80\x99s leading biotechnology companies. We are global collaborators who achieve together\xe2\x80\x94researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It\xe2\x80\x99s time for a career you can be proud of.

Global Safety Officer (GSO), Global Safety Medical Director, UK - Remote

Live

What you will do

Let\xe2\x80\x99s do this. Let\xe2\x80\x99s change the world. In this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and are a core member of the Executive Safety Committee (ESC).

You will serve as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as a delegate for the Therapeutic Area Head (TAH).

Responsibilities:

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Domestic and International travel up to 10%

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical Safety professional we seek is a leader with these qualifications.

Degree educated with MD or DO degree from an accredited medical school

Completion of an accredited medical or surgical residency

Clinical experience in either an accredited setting or private practice (including hospital based) is preferable

Product safety experience either in the bio/pharmaceutical industry or in regulatory agency.

Expertise with early development products, preferably in Oncology

Experience with marketed product safety; risk management.

Leadership experience of the safety profile of products assigned with cross-functional team members.

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\xe2\x80\x99 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.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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

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Amgen