Global Safety Manager (Registered Nurse)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Global Safety Manager (Registered Nurse)Live
What you will do
Lets do this. Lets change the world. In this vital role you will assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT), execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports, and execute quality assurance of vendor reviewed ICSRs.
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Support Quality Assurance of ICSR medical review
- Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.
- Act as MSRT product lead and/or therapeutic area lead if assigned
- Execute ICSR case escalation as appropriate
- Execute 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
- Support training to Amgen employees on ICSR medical review (if applicable)
- Participate in Safety Assessment Team (SAT)
- 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 his/her supervisor
- 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The observant professional we seek is a team-player with these qualifications.Basic Qualifications
- Clinical Nursing qualification and 1 year of related drug safety experience
- Medical Qualification (Nursing Degree); plus 3 years relevant work
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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.
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.