Consultant
Biocon · Bengaluru · onsite · Posted 41d ago
Undisclosed1–2 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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
Sourced from naukri
Skills
PharmacyBiotechnologyHealthcaremedical informationLife Sciences
About Biocon Limited
Biocon
Biotechnology
3.7k+
employees
1978
48 years old
Bangalore Rural, Karnataka
India
₹8.3L PA avg
Avg at Biocon Limited
About
We are a global biopharmaceutical company changing patients’ lives in over 120 countries by finding new and affordable ways to treat diabetes, cancer and autoimmune diseases.
Industries
BiotechnologyBiotech & Life sciences
Employee ratings
10 reviews
4.0/ 5
Culture
3.4
Career growth
2.4
Work-life
3.7
Employees rate it well for
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