16 days old

Global Safety Officer (Open to remote work)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    126097118
Amgen

Job ID: R-108084
Location: Thousand Oaks, CA, US

Amgen is seeking a Global Safety Medical Director at its main headquarters in Thousand Oaks, California to join the Global Patient Safety (GPS) organization reporting to the Executive Medical Director Global Safety. Other locations may be considered.

The Global Safety Therapeutic Areas 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.

The Global Safety Officer (GSO) serves 2 roles:
  • Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
  • Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). Serves 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 has management of Global Safety Physicians.

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


Basic Qualifications

MD or equivalent 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
  • Expertise in either Oncology, Hematology or Inflammation


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.



PI126097118
Posted: 2020-11-17 Expires: 2020-12-18

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Global Safety Officer (Open to remote work)

Amgen
Thousand Oaks, CA 91360

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