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февраль 2014 — июль 2016
2 года и 6 месяцев
Sandoz, г. Москва.
Medical Manager/ Medical Adviser:
Development and implementation of the medical part of the overall strategy and operational plan for the promotion of products of corresponding therapeutic areas according to the Company's overall strategy:
• prepares medical justification for the planned marketing strategies upon request and in the format requested by an internal client;
• upon request and in collaboration with the Business Unit defines and coordinates the plan for implementation of scientific and educational activities for the product (conferences, round tables, presentations/reports etc.);
• organizes and conducts training for internal clients on the products;
• provides medical information at the request of the Business Unit;
• develops educational materials for internal and external events (slides, reviews, presentations).
Establishment and development of interaction with federal Key Opinion Leaders in the relevant therapeutic area. Their involvement in the Company's scientific and educational projects (for example, scientific publications, educational seminars, lectures, presentations etc.);
Conducting scientific/medical expertise of the promotional and educational materials or activities initiated by the Company;
Conducting scientific expertise of new molecules and indications for use upon request and in collaboration with Market Access;
Functional management of medical projects and cross-functional projects;
Development and/or update of SOPs related to medical support of Business Units;
Support of grants and investigator initiated trials;
Support of product registration process;
Regularly updating and expanding own knowledge about the product, therapeutic area and clinical practice through self-education, participation in major national and international science congresses, communication with Key Opinion Leaders, etc.
Patient Oriented Program Coordinator:
Supervision of preparation, launch and implementation of POP together with global/local POP business partners to ensure compliance with the quality requirements and business objectives;
Act as an expert on all matters related to POP;
Ensure the availability of learning resources in the relevant unit, conduct or arrange seminars, trainings or sessions on experience sharing for the employees involved in POP;
Promote precise execution of the process in close cooperation with the POP initiators, pharmacovigilance manager and quality assurance department;
Ensure support and guidance to the POP initiators in matters of launch and implementation of the programs, as well as selection and quality assessment of the vendor;
Monitoring of actions on quality control required in accordance with the POP classification and POP monitoring;
Quality assessment of POP;
Ensure appropriate actions in case of negative results of POP quality assessment. Maintain communication with the department of quality assurance, pharmacovigilance manager and the POP global leadership council in the order required for development of the Corrective and Preventive Actions (CAPA) plan, and ensure control and status updates for the POP global unit and POP leadership council; ensure proper escalation of emerging issues to the management and their timely resolution by development of the CAPA plan;
Ensure proper control over the maintenance of POP SharePoint and timeliness of data update by the POP initiators, pharmacovigilance manager and others;
Maintain communication with the POP global unit on a regular basis;
Promote further improve of global business processes and quality standards for POP;
Together with the department of quality assurance and Pharmacovigilance Manager ensure preparedness to the POP audit/inspection, as well as participation of vendors in the audit, as needed.
Deputy Pharmacovigilance Manager:
Management of processes of collecting, processing, documentation, reporting and follow-up of all adverse events (AEs) in the application of all the products of the company "Sandoz"
Provision of processing, recording and tracking of receipt / submission / dissemination ICSR (Individual case safety report), serious adverse events reports (SAE), investigator notifications (IN), periodic safety update reports (PSUR) and annual safety reports (ASR) and ensure submission of relevant reports / submission / dissemination of reports on security / updates / information (ie, ICSR, SAE, IN, PSUR, ASR) to local health authorities in accordance with legal requirements.
Provide information reconciliation processes with other departments
Ensuring the availability of appropriate agreements (licensing / selling), including any agreements with third parties for the local licensees or licensors, to comply with all reporting requirements for ADR / AEs.
Ensuring permanent readiness for inspections of PV (pharmacovigilance).
Support for the audit and inspection by the health authorities, as well as the identification and implementation of appropriate corrective and preventive actions (CAPA).
Consideration and approval of proposals for marketing programs and web pages for the correct terminology, content and establishment of proper provision of information, as well as control over the collection and compilation of information on the reports related to AE.
февраль 2007 — февраль 2014
7 лет и 1 месяц
PPD Smolensk, Russia, г. Смоленск.
Clinical Review Specialist:
Performs review of clinical data as specified in the Manual Data Review Plan of the Data Validation Manual (DVM). Identifies potential data issues and ensures timely resolution by liaising with PPD project team and/or study sites. Ensures that all work conducted is completed to the acceptable quality in accordance with SOPs/WPDs, Protocol and DVM.
Ensures all required documentation, as defined in the SOPs/WPDs and DVM, is created and filed correctly. Provides accurate status information of all individual work conducted and, at the request of the CDM management, the overall study status.
Acts as a CRS Lead for several studies (coordination of review process, training process, established and maintain instruction guides, contact CDM Lead for each study related issues, control study access for reviewers and other)
• phase I/II acute leukaemia in paediatric patients
• phase III squamous NSCLC
• phase III non-squamous NSCLC
• phase III Nocturnal Asthma
• phase II paediatric Human Immunodeficiency Virus
• phase II active rheumatoid arthritis study
• phase III study bone metastases in subjects with advanced breast cancer
• phase IIIb Human Immunodeficiency Virus trial
• phase IIIb Human Immunodeficiency Virus trial.
• phase II paediatric Human Immunodeficiency Virus
Performed initiation, interim monitoring visits, close-out visits; used EDC with remote desktop connection, CTMS; used web based EDC, IVRS, central laboratory, performed feasibility visits; performed unblinded monitoring visits.