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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Global Safety Medical Director Haematology/ Oncology

LIVE

What you will do

In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety (GPS) and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global Safety Officer (GSO) serves 2 roles:

• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products supporting Hematology-Oncology portfolio.
• The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed.

Key activities

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness

WIN

What we expect of you

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

• Medical degree and full GMC registration
• Extensive pharmacovigilance (PV) experience.
• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Experience in the study/research and/or treatment of Oncology disease states

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.

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
• 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
• This Global role can be based in UK or US with flexible working available/ remote working available.

APPLY NOW

for a career that defies imagination

What we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.

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