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.
Global Safety Sr. Medical Scientist
Live
What you will do
Let’s do this. Let’s change the world. At Amgen, we are dedicated to delivering promising new therapies to patients with complex cancers, where there remains significant unmet need to improve outcomes. Our portfolio features many first-in-class oncology/hematology medicines and innovative therapies for recurring or difficult-to-treat cancers. Our industry-leading oncology pipeline has greater than 20 investigational assets, across multiple targets, in more than a dozen tumor types. We are proud to focus our research on difficult targets such as KRASG12C and to further explore our BiTE® technology.
In this vital role within the Global Patient Safety (GPS) organization, you will provide your medical expertise to the team to support the Global Safety Officer (GSO) in the conduct of safety assessments and risk management processes and activities for an assigned set of products through the product's life cycle. The Global Safety Physician is responsible for the conduct of safety monitoring and accountable for performing activities supporting product-related safety decisions and deliverables for assigned products.
The Global Safety Physician is responsible for the following:
Signal detection, evaluation, and management – performs data analysis to evaluate safety signals and authors analysis results for Safety Assessment Reports in collaboration with the GSO
Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents; review of AEs/SAEs from clinical trials as needed; reviews standard design of tables, figures, and listings for safety data from clinical studies; participates in development of safety-related data collection forms for clinical studies and participates in study team meetings as requested or needed
Directs the planning, preparation, writing and review of portions of aggregate reports
Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products
Authors various safety documents and health authority responses in collaboration with the GSO
Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepares and presents Global Patient Safety’s recommendations on safety issues to the cross-functional decision-making body
Assists GSO in the development of risk management strategy and activities
Supports activities related to new drug applications and other regulatory findings
Inspection readiness – undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
Be the representative and 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 safety professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
Preferred Qualifications:
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.
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.
careers.amgen.com
Amgen
Salt Lake City Utah
United States
Healthcare - Allied Health
(No Timezone Provided)
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.
Global Safety Sr. Medical Scientist
Live
What you will do
Let’s do this. Let’s change the world. At Amgen, we are dedicated to delivering promising new therapies to patients with complex cancers, where there remains significant unmet need to improve outcomes. Our portfolio features many first-in-class oncology/hematology medicines and innovative therapies for recurring or difficult-to-treat cancers. Our industry-leading oncology pipeline has greater than 20 investigational assets, across multiple targets, in more than a dozen tumor types. We are proud to focus our research on difficult targets such as KRASG12C and to further explore our BiTE® technology.
In this vital role within the Global Patient Safety (GPS) organization, you will provide your medical expertise to the team to support the Global Safety Officer (GSO) in the conduct of safety assessments and risk management processes and activities for an assigned set of products through the product's life cycle. The Global Safety Physician is responsible for the conduct of safety monitoring and accountable for performing activities supporting product-related safety decisions and deliverables for assigned products.
The Global Safety Physician is responsible for the following:
Signal detection, evaluation, and management – performs data analysis to evaluate safety signals and authors analysis results for Safety Assessment Reports in collaboration with the GSO
Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans and other clinical study-related documents; review of AEs/SAEs from clinical trials as needed; reviews standard design of tables, figures, and listings for safety data from clinical studies; participates in development of safety-related data collection forms for clinical studies and participates in study team meetings as requested or needed
Directs the planning, preparation, writing and review of portions of aggregate reports
Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products
Authors various safety documents and health authority responses in collaboration with the GSO
Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepares and presents Global Patient Safety’s recommendations on safety issues to the cross-functional decision-making body
Assists GSO in the development of risk management strategy and activities
Supports activities related to new drug applications and other regulatory findings
Inspection readiness – undertakes activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness
Be the representative and 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 safety professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
Preferred Qualifications:
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.
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.
careers.amgen.com