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Medical Review Senior Medical Scientist

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 14, 2023

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Discipline
Science/R&D, Biotechnology
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

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.

Medical Review Senior Medical Scientist

Live

What you will do

Lets do this. Lets change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.

Responsibilities:
  • Assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
  • Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
  • You will be the point of contact between Case Management and GSOs on medical content and regulatory reporting of ICSRs
  • Act as MSRT process lead and support the development, training on and implementation of new processes in MSRT (if applicable)
  • Support training to Amgen employees on ICSR medical review
  • Mentor junior medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on their therapeutic or functional team
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a key contributor with these qualifications.

Basic Qualifications:
  • MD or DO degree from an accredited medical school

Preferred Qualifications:
  • MD/DO or international equivalent plus 3 years relevant work
  • Knowledge of Amgen case management and medical review SOPs and regulatory requirements for Pharmacovigilance
  • Clinical knowledge of therapeutic area patient populations and drug class
  • Proficiency in technical safety systems including the Amgen Safety database and medical coding
  • Knowledge of safety data capture in clinical trials and in the post marketing environments
  • Knowledge of clinical trials and drug development
  • Knowledge of Amgen products and patient population

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.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 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.

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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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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