Global Safety Medical Director, Obesity - US, Remote

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 Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

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What you will do

Let’s do this. Let’s change the world. In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and will be 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) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians.

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

• Communicate and articulate Safety’s position clearly and effectively in cross-functional meetings and written documents.

• Produce high-quality documentation that meets Amgen's standards.

• Travel: Domestic and International travel up to 10% may be essential

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What we expect of you

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

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

Completion of an accredited medical or surgical residency

OR

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

Preferred Qualifications:

• Obesity and …