Global Safety Officer - Cambridge, Cambridgeshire, United Kingdom - Amgen SA

Description

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. Global Safety Officer (GSO), Global Safety Medical Director, Oncology, UK - Remote

In this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and are a core member of the Executive Safety Committee (ESC).

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
Domestic and International travel up to 10%
The Medical Safety professional we seek is a leader with these qualifications.
MD or DO degree from an accredited medical school
Completion of an accredited medical or surgical residency or clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Product safety experience either in the bio/pharmaceutical industry or in regulatory agency.
Expertise in Oncology therapeutic area, or clinical training.
Experience with marketed product safety; risk management.
Leadership experience of the safety profile of products assigned with cross-functional team members.

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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.
#