Medical Review Senior Associate Scientist

Job Description:

Responsibilities

•  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

Qualification & Expeirence

•  MD/DO or international equivalent and 1 year of related drug safety experience
•  MD/DO or international equivalent plus 3 years of relevant work