AddressHOW 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.
Global Safety Sr Medical Scientist
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products and support global individual case safety reports regulatory reporting compliance.
Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
Act as MSRT product lead and/or therapeutic area lead as assigned
Complete ICSR case issue to GSO as appropriate
Implement appropriate case follow up per SOPs
Support medical coding conventions, and systematic process improvements for ICSR medical review
Maintain list of expected terms in the auto label tool
Monitor the compliance of autolabel tool updates
Support Quality Assurance of ICSR medical review
Act as MSRT process lead and support the development, training on and implementation of new processes in MSRT
Support training to Amgen employees on ICSR medical review
Mentor junior medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on their therapeutic or functional team
Participate in Safety Assessment Team (SAT)
Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product problems.
Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP)creation, and metrics with regards to medical review
Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor
Inspection Readiness:
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be 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 outstanding contributions to serve patients. The professional we seek is a Senior Medical Scientist with these qualifications.
Basic Qualifications:
Doctorate degree and 3 years of experience
OR
Master’s degree and 6 years of experience
OR
Bachelor’s degree and 8 years of experience
Preferred Qualifications:
MD/DO or international equivalent plus 3 years relevant work
Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance
Clinical knowledge of therapeutic area patient populations and drug class
Proficiency in technical safety systems
Knowledge of safety data capture in clinical trials and in the post marketing environments
Knowledge of clinical trials and drug development
Knowledge of Amgen products and patient population
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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 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.
