Consultant

Monitor country/region-specific MI escalation mailboxes for Europe, the NorAm and emerging marketsMaintain a thorough understanding of country-specific prescribing information, pack inserts, product monographs, and standard response documents for each marketed product in different countriesReview and record the escalated MI inquiries from Eversana in each mailbox (from Europe, the NorAm and emerging markets)Create a scientific response to each medical inquiry in consultation with the TA leads, the MI lead and the medical writing teamCoordinating with cross-functional teams, including but not limited to Quality, RND, Regulatory, PV and other functions as needed for input to respond to the inquiriesCreate a standard response document for complex MI inquiries in consultation with TA leads, MI lead and medical writing teamEnsure the MI responses are Scientific, accurate, fair and balanced and referenced to the approved product prescribing information/labelling and country-wise regulatory requirementsEnsure MI responses are only scientific in nature, that address the exact nature of the inquiry, and that the response is not promotional in natureEnsure to send the final drafted response to the MI lead for review and implement the comments/changes before sharing the final responseEnsure 100% all escalated medical inquiries are responded to within 7 working daysEnsure to record and provide a monthly report of all inquiries received and addressed from each region (from Europe, the NorAm and emerging markets)Ensure implementation of corrective actions for errors that were identified in the response/process or deviationsMaintain the lifecycle of the standard response documents in terms of annual revision, review and creating a final clean version for review and approval by the MI leadProvide information to the Medical affairs/other cross-functional teams in terms of analysis/ other relevant medical information-related requests on a need basisSupport the MI lead in terms of medical information operations management with Eversana and internal cross-functional teams