Medical Review Scientist

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

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

• 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)