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

Global Safety Sr Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will support conduct of benefit- risk management processes and activities for Amgen products in assigned therapeutic area(s). Ensures that benefit-risk management (B-RM) processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Establishes and maintains Amgen corporate benefit-risk management processes, roles and responsibilities.

• Provides guidance and subject matter expertise on risk management and risk minimization strategy across Amgen product portfolio
• Provide guidance and subject matter expertise to the assigned therapeutic areas on benefit- risk assessment strategies and ensure consistency across Amgen product portfolio
• Provide risk minimization benchmarking and scenario planning to identify best strategies for risk minimization and measurement of effectiveness of risk minimization measures for the assigned products
• Provides centralized support, training, and leadership for Safety and cross-functional members who work on benefit-risk assessments, risk management plans, risk minimization (including REMS), and risk communications.
• Provide input for the development and updates of respective standards, guides and templates related to benefit-risk management.
• Ensure Amgen adheres to and is aligned with Global Health Authority regulations regarding risk management practices
• Provide input and guidance on benefit risk related the patient perspective studies processes and deliverables
• Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit risk management
• Monitors/reports risk management metrics and reports to assure Amgen is in compliance with global benefit/ risk management standards
• Participates in the development of recommendations in the process of risk management tracking and necessary compliance system improvements
• Supports inspection and audit activities with regards to the RM processes within Safety, be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Assist in creations of core structured benefit-risk assessments, core Risk Management Plans (RMPs), and EU RMPs.
• Supports development of risk management plans in modular format and cross-use and reference of modules in PBRER etc.
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is a partner with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of Pharmacovigilance experience OR
• Master’s degree and 6 years of Pharmacovigilance experience OR
• Bachelor’s degree and 8 years of Pharmacovigilance experience OR
• Associate’s degree and 10 years of Pharmacovigilance experience OR
• High school diploma / GED and 12 years of Pharmacovigilance experience

Preferred Qualifications

• Doctorate degree, M.S.,B.S. in health science with significant advanced training. Knowledge of medical, clinical or pharmacovigilance is required.
• Minimum 5 years of pharmaceutical/industry experience with 3 years in global drug safety and risk management. Familiarity with management of performance metrics is desirable.

• Scientist, research scientist experience planning implementation/minimization

• Program evaluation methods, qualitative and quantitative

• Value generation experience

• Experience across multiple therapeutic areas

• Experience in leading and managing teams

• Demonstrated knowledge of global aspects of drug safety

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

• Strong knowledge of global safety reporting activities, regulations, and guidelines

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

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