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Manager / Sr.manager - Medical Advisor ( Pharmaceutical)

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

To assist the pharmacological activities in UK as safety / medical advisory to EU QPPV.Review of annoymised single patient reports & Individual case safety reportsMonthly medical review meeting on skype with UK to ensure proper implementation of vigilance system.Weekly literature survey & safety cases review for UK.Medical annual safety review for all products registered in UK.Preparations & review of periodic safety update reports.Preparation of Risk Mitigation PlansPreparation of Expert reports.Review & comment on adverse event cases from USA & UKMedical comments on expectedness & unexpectedness of the adverse events for expediting cases to UKMHRA & EVHUMANReview of the pharmacovigilance agreement with the export partners of FDC. RegulatoryPreparation & review of medical rationales for old combinations & new drugs for submission to DCGIPreparation & review of medical data for regulatory submission to foreign regulatory authorities.Preparation & review of pack insert, patient information leaflet (PIL), Summary of product characteristics (SmPC) for export license applicationPreparation of scientific product rationales for submission to DCGI.DCGI dossier preparation & Review.Common technical documents review Clinical Studies To conduct clinical trials & BA/BE studies with assistance from external CROs.To conduct MIC studies as per requirementsPreparation & review of PMS protocolsMEDICO-MARKETINGTo answer medical queries raised by doctors and field staff and other customers related to productsTo answer with justification for any complaints related to products from patient safety, regulatory & pharmacovigilance perspective.Review, comment & approval on product brief regarding regulatory status, dosage, indication of the proposed launchesContribute to new product launches by proper and timely execution of regulatory processes and contributes to positioning through literature surveys, clinical trials.To prepare and update medical content of prescribing information of products.To prepare of new product monographs / product brochures/ patient information leaflets.To ensure close and positive interaction between medical and marketing to help sharpen promotional strategies and their implementationSupport to training department for specials topics teaching & question answer sessionTo review and approve promotional materials in compliance with SOPs developed by myself based on OPPI guidelines & IFPMA code.Provide marketing with new scientific information on products, competitors, opportunities and/or therapeutic areas for possible incorporation into promotional materials.Providing scientific references required in preparation of LBL & VA relating to labeled indications & also additional indications.
Degree: MD/ MS (Medicine)

Additional Degree: MBBS

Experience: 6-11


Clinical Research | Pharmaceutical Research
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