Global Safety Manager (Registered Nurse)

This Group's purpose is to provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.

This Global Safety Manager position 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.

Key Responsibilities include:

• 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

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

Basic Qualifications

• Clinical Nursing qualification and 1 year of related drug safety experience

Preferred Qualifications

• Medical Qualification (Nursing Degree); plus 3 years relevant work

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, as well as work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen!

Amgen provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.

As an organization dedicated to improving the quality of life for people around the world, Amgen champions 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If 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.