Global Safety Officer (GSO), Global Safety Medical Director, Oncology

Amgen Inc.

3.6

(9)

Multiple Locations

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-175802

    Position summary

    cts.

    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.

    Basic Qualifications:

    MD or DO degree from an accredited medical school

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

    • Expertise in Oncology therapeutic area, or clinical training.

    • 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, so we work to care for our teammates' professional and personal growth and well-being.

    • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent

    • 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.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging