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Medical Review Scientist
Amgen
posted 25d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Medical Review Scientist
What you will do
Lets do this. Lets 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
To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Doctorate degree OR
Masters degree and 4 to 6 years of relevant experience OR
Bachelors degree and 6 to 8 years of relevant experience OR
Diploma and 10 to 12 years of relevant experience
Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Implement ICSR case escalation as appropriate Implement appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input 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 Preferred Qualifications:
Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding 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 (preferred)
What you will do
Lets do this. Lets 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Doctorate degree OR
Masters degree and 4 to 6 years of relevant experience OR
Bachelors degree and 6 to 8 years of relevant experience OR
Diploma and 10 to 12 years of relevant experience
Inspection Readiness:
Employment Type: Full Time, Permanent
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What Amgen employees are saying about work life
based on 10 employees
Flexible timing
Monday to Friday
No travel
Night Shift
Amgen Benefits
Submitted by Company
Health Insurance Child care Education Assistance Employee volunteer program and company matching donation program Flexible work environment Competitive base pay and annual bonus opportunities
Submitted by Employees
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