Global Safety Medical Director
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Jul 23, 2019
View more
- Discipline
- Administration, Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
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. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
- 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
- Travel: Domestic and International travel up to 10% may be essential
Basic Qualifications
MD or DO degree from an accredited medical school
2 or more years of industry pharmacovigilance (PV) experience
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting.
Preferred Qualifications
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Previous management and/or mentoring experience
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.
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.
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We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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