Job details
Job type full-time
Full job description
Career category
Medical services
Job description
How might you defy imagination?
If you feel like you’re part of something bigger, it’s because you areAt amgen, our shared mission—to serve patients—drives all that we doIt is key to our becoming one of the world’s leading biotechnology companiesWe are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwideIt’s time for a career you can be proud ofJoin us.
Global safety sr medical scientist
Live
What you will do
Let’s do thisLet’s change the worldIn this vital role you will serve as the medical expert for the team to support the global safety officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products.
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 patientsThe professional we seek is a go-getter with these qualifications.
Basic qualifications
Md, do or medical degree from an accredited medical school and 2+ years of work 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
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Clinical/medical research experience
Product safety in the bio/pharmaceutical industry
Previous management and or mentoring experience
Experience in leading teams and or projects
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.
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
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 doubtJoin us.
Careers.amgen.com
Equal opportunity statement
Amgen is an equal opportunity employer and will consider you without regard to your 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 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.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the san francisco fair chance ordinance.
