Consultant

Biocon Biologics; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Biocon Biologics in Bengaluru seeks a Medical Information Specialist to monitor MI escalations across Europe, NorAm, and emerging markets, and to maintain country-specific prescribing information and product monographs for marketed products.

You will prepare scientific responses in consultation with TA leads, the MI lead and medical writing, ensuring responses are non-promotional, accurate, and aligned with country-specific regulatory requirements; you will also track turnaround times and

Job description

• Monitor country/region-specific MI escalation mailboxes for Europe, the NorAm and emerging markets
• Maintain a thorough understanding of country-specific prescribing information, pack inserts, product monographs, and standard response documents for each marketed product in different countries
• Review 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 team
• Coordinating with cross-functional teams, including but not limited to Quality, RND, Regulatory, PV and other functions as needed for input to respond to the inquiries
• Create a standard response document for complex MI inquiries in consultation with TA leads, MI lead and medical writing team
• Ensure the MI responses are Scientific, accurate, fair and balanced and referenced to the approved product prescribing information/labelling and country-wise regulatory requirements
• Ensure MI responses are only scientific in nature, that address the exact nature of the inquiry, and that the response is not promotional in nature
• Ensure to send the final drafted response to the MI lead for review and implement the comments/changes before sharing the final response
• Ensure 100% all escalated medical inquiries are responded to within 7 working days
• Ensure 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 deviations
• Maintain 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 lead
• Provide information to the Medical affairs/other cross-functional teams in terms of analysis/ other relevant medical information-related requests on a need basis
• Support the MI lead in terms of medical information operations management with Eversana and internal cross-functional teams