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Benefit-Risk Management Scientist

Expired Job

Amgen Inc. Thousand Oaks , CA 91360

Posted 2 months ago

Career CategorySafetyJob Description

Amgen is hiring a Benefit

  • Risk Management Scientist to work out of their Thousand Oaks, CA or their Cambridge, MA location.

This position will support Global Safety Teams in conducting benefit-risk management processes and activities. The Benefit

  • Risk Management Scientist works under the direction of the Global Risk Management Officer to ensure that benefit-risk management processes are continuously improved to reflect regulatory trends and guidelines, are patient-centered and represent best in class.

The Benefit

  • Risk Management Scientist negotiations with partner functions (e.g., Clinical Development, Regulatory, Biostatistics, Business Partners) to achieve the most effective integration of all available skills, tools and data into benefit-risk management processes and deliverables (e.g., core structured benefit-risk assessment, Effects Tables and Value Trees; Risk Management plans) to ensure development of the most accurate and effectively presented benefit-risk assessment for Amgen products throughout the product lifecycle and to maximize patient safety. In developing benefit-risk assessments, seeks to incorporate the patient perspective whenever possible.

Additional Responsibilities of the Benefit

  • Risk Management Scientist are:
  • Assists Global Risk Management Officer in developing training for cross-functional contributors to benefit-risk management documents

  • Supports development of core structured benefit-risk assessment document (including Effects Table and Value Tree) and the integration of benefit-risk assessments in the PSUR/PBRER and Clinical Overview; REMS, and contributes to the risk management sections of the core and EU Risk Management Plans; Conducts Risk-Benefit Assessment for drug-device combinations

  • Provides support, expertise and best in class practices to Safety teams in preparation of benefit-risk assessments and risk management planning to ensure highest quality and consistency across Amgen's products in approach to benefit-risk assessment and benefit-risk management

  • Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit-risk management

  • Supports inspection and audit activities, and other compliance-related activities with regard to benefit-risk management processes

  • Represents the activities of benefit-risk management process planning in internal and external committees

  • Helps characterize risks related to Amgen products, identify best strategies for risk minimization and measurement of effectiveness of risk minimization measures

  • Conducts Risk-Benefit Assessment for Amgen drug-device combination products

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Scientific experience,

OR

Bachelor's degree and 5 years of Scientific experience

OR

Associate's degree and 10 years of Scientific experience,

OR

High school diploma / GED and 12 years of Scientific experience

Preferred Qualifications:

  • BS Degree

  • One year work experience in the pharmaceutical industry

  • Familiarity with industry principles of drug safety, drug development and pharmacology, biostatistics, clinical trial methodology and pharmacoepidemiology

  • Expertise in benefit-risk assessment methodologies, risk minimization design, implementation and evaluation

  • Excellent verbal and written communication skills, including formal presentation skills

  • Demonstrated success in navigating a highly-matrixed based organization to deliver against complex program plans

  • Works effectively when co-located with, and when remote from, product teams/leaders/managers

  • Demonstrated ability to handle more than one complex project simultaneously

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.

.


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Benefit-Risk Management Scientist

Expired Job

Amgen Inc.