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Global Safety Medical Director, Obesity - Us, Remote

7+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

How Might You Defy Imagination?

At Amgen, you’re not just joining a company – you’re joining a mission. Our shared commitment to serving patients drives us to become one of the world’s leading biotechnology companies. As global collaborators, we work together to research, develop, and deliver life-changing products that impact over 10 million patients worldwide. It’s time for a career you can be proud of.


What You Will Do

In this critical role within the Global Patient Safety (GPS) organization, the Global Safety Officer (GSO) will be the safety expert for assigned development products, guiding the direction, strategy, and pharmacovigilance activities for those products throughout their lifecycle. You will take accountability for the overall safety profile and all product-related decisions and deliverables. Additionally, you will lead the Safety Analysis Team (SAT), the Global Safety Team (GST), and be a core member of the Executive Safety Committee (ESC). You’ll also collaborate with other cross-functional teams and represent the Therapeutic Area Head (TAH) when needed.

Responsibilities:

  • Lead and validate safety signals and conduct thorough safety signal assessments.
  • Develop and maintain Core Safety Information, such as core data sheets and informed consent forms.
  • Prepare and review core and regional Risk Management Plans, including risk minimization strategies.
  • Contribute to safety sections of aggregate reports, clinical protocols, statistical analysis plans, and clinical study reports.
  • Review safety content for new drug applications and other regulatory filings.
  • Serve as a safety expert on the Evidence Generation Team for assigned products.
  • Maintain inspection readiness and ensure compliance with regulatory requirements.
  • Communicate safety positions clearly and effectively in meetings and written reports.
  • Produce high-quality, compliant documentation that meets Amgen’s standards.
  • Travel up to 10% domestically and internationally.

What We Expect of You

We seek a leader who combines clinical expertise with strategic safety management experience. The ideal candidate will have the following qualifications:

Basic Qualifications:

  • MD or DO degree from an accredited medical school.
  • Completion of an accredited medical or surgical residency, or equivalent clinical experience in an academic or private practice setting.

Preferred Qualifications:

  • Experience in Obesity and related conditions.
  • At least 2 years of industry pharmacovigilance (PV) experience.
  • Experience in product safety within the biopharmaceutical industry or a regulatory agency.
  • Previous management or mentoring experience.
  • Board certification or equivalent clinical training.

What You Can Expect of Us

At Amgen, we are committed to advancing your personal and professional growth. In addition to a competitive salary, we offer a comprehensive Total Rewards Plan, which includes:

  • Generous Retirement and Savings Plans with company contributions.
  • Medical, Dental, and Vision coverage, life insurance, and flexible spending accounts.
  • Discretionary annual bonus and stock-based incentives.
  • Award-winning time-off policies and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements.

The expected annual base salary for this role in the U.S. is $250,578 to $304,707.


Apply Now

If you’re ready to make a difference, [Apply Now] and be part of a team that’s dedicated to changing the world.


Amgen is an Equal Opportunity Employer

Amgen values diversity and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. We are committed to providing reasonable accommodations to individuals with disabilities throughout the application process.