Medical Review Senior Associate Scientist

Organization: Global Patient Safety

Team: PV Operations

Group Purpose: 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.

Job Summary:

• To 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.
• To act as a point of contact for Case Management on medical content of ICSRs
  
  

Key Activites:

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
• 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
• Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.
• Support Quality Assurance of ICSR medical review (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 (if applicable)
• 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
  
  

Knowledge and Skills :

• 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 Safety Database and medical coding
• Knowledge of safety data capture in Clinical Trials and Post Marketing setting
• Knowledge of clinical trials and drug development
• Knowledge of Amgen products and patient population (preferred)
  
  

Education & Experience (Basic):

• MD/DO or international equivalent and 1 year of related drug safety experience
  
  

Education & Experience (Preferred) :

• MD/DO or international equivalent plus 3 years of relevant work