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Global Safety Medical Officer - General Medicine

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Nov 11, 2022

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Global Safety Medical Officer General Medicine

Live

What you will do

Lets do this. Lets change the world. In this vital role you will serve two primary functions:

A safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. Be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Physicians.

Below are the key responsibilities:
  • Accountable for the overall safety profile and all product-related decisions and deliverables for assigned product (s)
  • Accountable for Product safety profile, benefit-risk evaluation, and risk communication for the assigned product
  • Develop signal detection strategy, evaluate safety signal detection findings, validate signals, need for further actions on safety issues, cross-functional discussion, and further communication as needed and lead safety signal assignments
  • Develop and maintain core reference safety information like Development Core Safety Information (DCSI), and Core safety information portions of Core Data Sheet (CDS)
  • Prepare and review core and regional risk management plans including additional risk minimization measures
  • Prepare and review safety sections of periodic aggregate reports
  • Provide safety input to protocols, statistical analysis plans, and clinical study reports
  • Prepare and review safety section of new drug applications and other regulatory filings
  • Serve as safety expert Evidence Generation Team for assigned products; Participate in safety governance meetings per Standard Operating Procedures and Manuals such as Facilitates, Chairs, and Presents
  • Participate in cross-functional teams and serve as the delegate for the Therapeutic Area Head
  • Be a representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Develop a strategy as needed for updating safety-related portions of Investigators Brochure and Informed Consent Form
  • Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs)
  • Travel: Domestic and International travel up to 10% may be essential

While this position is based at our main headquarters in Thousand Oaks, California, other locations may be considered.

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.

Basic Qualifications:

MD or DO degree from an accredited medical school with 2 years of industry pharmacovigilance (PV) experience

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:

Product safety in the bio/pharmaceutical industry or regulatory agency; previous management and/or mentoring experience; board certification or equivalent training.

Experience in related disease areas including General Medicine, Metabolic, Cardiac or Internal Medicine.

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.

careers.amgen.com

    Join Us

    If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

    Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

    As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

    Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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 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 accommodation.

    Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

    Company

    We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

    We live the mission.

    We win together.

    We thrive on continual challenge.

    Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

    At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

    Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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    Find Us
    Website
    Phone
    805-447-1000
    Location
    Corporate Headquarters
    One Amgen Center Drive
    Thousand Oaks
    California
    91320-1799
    US
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