Career Category

Safety

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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Live

What you will do

Let’s do this. Let’s change the world. Global Safety Medical Directors serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

• 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

• 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 Safety professional we seek is a clinical and scientific expert with these qualifications.

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

• 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

• Expertise in Immuno-oncology

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.

• 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

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.