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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.

Senior Manager, Pharmacovigilance Operations Commercial & Study Liaison

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you and your team will help in the development of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities (eg patient support programs and market research) in compliance with global regulatory requirements and Amgen compliance policies and standards.

• Review, approve and execute PV Operations safety data collection strategies
• Participate in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency
• Ensure the strategies of the department are implemented into the safety related organized data collection activities to ensure Amgen remains compliant with global safety legislation and requirements
• Provide consultation to Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data
• Act as a liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be a point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents
• Initiate and support activities to ensure PV Operations input to commercial initiatives
• Responsible for developing and supporting strong cross-functional relationships and communication
• Develop and communicate plans/objectives
• Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement, and standardization of new processes and methods
• Own the implementation of new processes and methods within and across Global Patient Safety
• Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Act as point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The pharmecovigilance professional we seek is a driven and passionate person with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience, OR
• Master’s degree and 6 years of directly related experience, OR
• Bachelor’s degree and 8 years of directly related experience, OR
• Associate's degree and 10 years of directly related experience AND
• 2+ years of managerial experience directly supervising people, and/or similar leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Ability to effectively represent ideas professionally, both verbally and in writing to a diverse audience
• Expert knowledge of the global safety environment, regulations, and guidance
• Project and/or Process Management experience & knowledge
• Strong understanding of safety data capture, representation, and interpretation
• Deep knowledge of related regulatory/industry considerations, compliance issues, and/or scientific discovery
• Ability to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally
• High attention to detail and the ability to organize, plan, and prioritize workloads for the function/team

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.

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