5 days old

Global Pharmacovigilance (PV) Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    126258495
Amgen

Job ID: R-107454
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Global Pharmacovigilance (PV) Scientist

Live

What you will do

Let's do this. Let's change the world. In this vital role you will join a team of PV Scientists working in collaboration with Global Safety Officers (GSO) to provide the safety strategy and major safety deliverables for Amgen product. The Immuno-oncology team has an exciting portfolio of products ranging from Early Development through the Post marketing settings. We need collaborative and innovative world-class talent to ensure these molecules to ensure these molecules and medicines reach their full potential while helping patients.
  • Contributes to the planning, preparation, writing and review of periodic aggregate safety reports
  • Review of adverse events and serious adverse events from clinical trials
  • Review and provide input and support on study protocols, statistical analysis plans and other
  • Review standard design of tables, figures, and listings for safety data from clinical studies.
  • Conduct signal detection, evaluation, and management
  • Prepare safety assessment reports and other safety documents and regulatory responses
  • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
  • Participates in Safety Governance per Amgen processes
  • Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making bodies
  • Assist GSOs and other Senior PV Scientists in the development of risk management strategy and activities
  • Provides contents for risk management plans
  • Update strategy and content for regional risk management plans


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The PV professional we seek is a subject matter expert with these qualifications.

Basic Qualifications:

  • Doctorate degree OR
  • Master's degree and 3 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
  • Bachelor's degree and 5 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
  • Associate's degree and 10 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
  • High school diploma / GED and 12 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience


Preferred Qualifications:

  • Health care professional background
  • 1 year of drug safety/PV experience
  • Experience in signal detection, evaluation and management
  • Experience as a contributor to periodic aggregate safety reports
  • Experience with literature surveillance: source document review, knowledge, and skills
  • Experience with the Argus Safety database
  • Good clinical and scientific judgment
  • Clinical and/or medical research experience
  • Strong written and verbal communication skills


Thrive

Some of the vast rewards of working here

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.
  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A 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-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor


Apply nowfor a career that defies imagination

Objects in your future are closer than they appear. 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.

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.



PI126258495
Posted: 2020-11-20 Expires: 2020-12-21

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Global Pharmacovigilance (PV) Scientist

Amgen
Thousand Oaks, CA 91360

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