Global Safety Sr. Medical Scientist- Global Safety Physician, US- Remote
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Global Safety Sr. Medical ScientistLive
What you will do
Lets do this. Lets 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 Safetys 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
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 schoolPreferred Qualifications:
- Clinical/medical research experience in Oncology
- Product safety or clinical development experience in the biotech or pharmaceutical industry
- Previous management and/or mentoring experience
- Experience in leading teams and/or projects
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.
- Vast opportunities to learn and move up and across our global organization
- 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided 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 accommodation.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.