Maxim Mily

Management of drug therapy and pharmaceuticals supply.
- Maintenance of drug formulary system;
- Development of local treatment protocols;
- Monitoring of pharmaceuticals utilization;
- Planning of pharmaceuticals provision;
- Safety monitoring, adverse reactions reporting;
- Clinical consultations in difficult cases, signatory role for administration of pharmaceuticals from restricted list;
- Education of internal clients in phermacotherapy questions;
- Interactions with pharma industry.

Upgrading and maintenance of MAH Pharmacovigilance System, deputy QPPV.
Responsibilities for running of all critical PhV processes:
- Registration and processing of individual sponteneous adverse events reports;
- Identification and processing of safety signals;
- Literature monitoring;
- Preparation and revision of pharmacovigilance documents (RMP, PSUR, Master-File, SOP)
- Training of personal and external partners et c.
Communications with regulatory agency.

Main responsibilities.
• Expertize of dossiers submitted for registration, confirmation of registration, and variations
• Expertize of pharmacovigilance documents (PSUR, RMP)
• Preparation of responses for inquiries from health care organizations and other authorities
• Participation in development of regulatory documents

Main responsibilities.
• Interactions with OLs
• Preparation and delivery of product and general trainings, promotional materials for field force;
• Approval of promotional and none-promotional materials;
• Revision and approval of clinical overview and clinical summary of registration dossier, SPCs, PILs;
• Initiation and coordination of clinical trials with company products in countries of presence, publications management; presentations on scientific governings;
• Conduction health economic evaluations for company products for markets under responsibility;
• Preparation of EDL and formulary submissions;
• Commercial assessment of products planned for launch, estimation of pharmacoeconomically grounded price.

Main responsibilities.
Market access activities:
• Development and execution of market access strategies for existing and planned products; preparation of EDL and formulary submissions
• Conduction of attributable for Belarus health economic evaluations, creation of cost-effectiveness and budget-impact models for Amgen products
• Contacts with KOLs and payers, publications management; presentations on scientific governings.
Business development activities:
• Commercial assessment of products and medical devices (market analytics, evaluation of disease epidemiology and current therapeutic practice, preliminary economic evaluations and pricing, sales forecasting)
◦ from portfolios of existing partners (Amgen, Orkla, CookMedical)
◦ proactive search for perspective products and partners

Main responsibilities:
• Creation of health economics part of dossiers for inclusion in EDL and other lists;
• Planning, organization of involvement of third-party vendors, monitoring and appraisal of pharmacoeconomics evaluations of company products;
• Management of publications and presentations on pharmacoeconomic evaluations of company products;
• Building of relations with KOLs in the field of health economics;
• Organization and conduction of educational and scientific event with market/access health economics agenda;
• Delivery of trainings in general questions of health economics and evaluations of the products for company personal;
• Development, implementation, and maintenance of interactive Market Access Tool for iPAD
• Support of global brand teams in operations in the field of Health Economics;

Main responsibilities:
• Preparation and delivery of product and general trainings for field force;
• Preparation of promotional materials;
• Medical writing (clinical overview and clinical summary of registration dossier, SPCs, PILs);
• Safety surveillance for company products;
• Information support for internal and external clients;
• Initiation and coordination of clinical trials with company products in countries of presence, contacts with OL;
Participation of preparation of formulary submissions in countries of presence.