Global Safety Officer, Oncology/Hematology
About the Job
Amgen is seeking a Global Safety Medical Director to join the Global Patient Safety (GPS) organization reporting to the Executive Medical Director Global Safety.
The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety 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 and is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
- Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). Serves as a member of the Evidence Generation Team and other relevant cross functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and has management of Global Safety Physicians.
- 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
- Travel: Domestic and International travel up to 10% may be essential
MD or equivalent degree from an accredited medical school with 2 years of industry pharmacovigilance (PV) experience
Completion of an accredited medical or surgical residency
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Previous management and/or mentoring experience
- Board Certification or equivalent training
- Expertise in Hematology/Oncology
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.