
Eldar Kutumov
Торговый агент,супервайзер

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About me
Clinical Project Manager / QPPV – Pharmaceutical company
Education

Center for Examinations and Tests in Health Service UE of the Republic of Belarus.
2016 - 2016Drug safety and pharmacovigilanceRisk management systems/Periodic safety update report/Signal management

Federal State Institution «Scientific Centre of Medical Products» Health Ministry of Russia
2015 - 2015Drug safety and pharmacovigilanceSeminar

North-Western State Medical University named after I.I. Mechnikov
2007 - 2008
Saint-Petersburg State Pediatric Medical University
2001 - 2007Activities and Societies: Biochemistry Microbiology Neurosurgery
Experience

ЗАО «Веда-Маркет»
Sept 2006 - May 2007Торговый агент,супервайзер1.Реализация товара на территории2.Выполнение плана по объему, по брендам3.Разработка и проведение маркетинговых акций‚ составление винных карт‚ разработка ассортиментных и коммерческих предложений4.Поддержание и развитие существующей клиентской базы5.Контроль дебиторской задолженности6.Документооборот7.Ведение отчетности

OOO "Winfuture"
Jun 2008 - Nov 2008Руководитель/CEOОрганизация бизнеса с нуля, управление продажами, обучение персонала.Изучение покупательского спроса, регулирование ассортимента товара, контроль за реализацией, планирование/отчетность (анализ продаж), рекламаОрганизовывать подготовку и заключение договоров на поставку продукции потребителямВозглавлять работу по составлению планов поставок продукцииПринимать меры по выполнению плана реализации продукцииОрганизовывать оптовую торговлю продукцией предприятия на закрепленной территории.Выполнение плана продажРазработка стратегии продвижения направленияУстановление партнерских отношений с поставщиками и заказчиками. Show less

Инфографика Казахстан
Dec 2010 - Jan 2013Руководитель/CEOОрганизация бизнеса с нуля, управление продажами, обучение персонала.Изучение покупательского спроса, регулирование ассортимента товара, контроль за реализацией, планирование/отчетность (анализ продаж), рекламаОрганизовывать подготовку и заключение договоров на поставку продукции потребителямВозглавлять работу по составлению планов поставок продукцииПринимать меры по выполнению плана реализации продукцииОрганизовывать оптовую торговлю продукцией предприятия на закрепленной территории.Выполнение плана продажРазработка стратегии продвижения направленияУстановление партнерских отношений с поставщиками и заказчиками.Инфографика/информационный дизайнWEB - программирование Show less

BIOCAD
Mar 2013 - Apr 2014CRA/Clinical Research AssociateAssistance with preparation of submissions to local authorities and ethical committees;Assistance with the management of agreements with investigational centers;Assistance the project team with accurately updating and maintaining clinical tracking systems;Responsibility for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports;Performing investigator evaluation and recruitment through the use of questionnaires and CTMS;Performing study tracking to ensure that all study files and documents are accurate, current and complete;Execute site closeout activities;Manage recruitment implementing appropriate contingency plans as needed;Facilitate preparation and collection of site level documents;Execute site initiation and training activities;Perform monitoring visits according to monitoring plan;Manage site drug supply management;Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial;Data Handling, Reporting and Tracking & administrative tasks;Assists with managing site payments;Assists with the tracking and management of Case Report Forms (CRFs), queries;Site management and site staff performance including monitoring all types of clinical trials ensuring adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures. Show less

Solopharm
Sept 2014 - now1. Organize and oversee the receipt, evaluation, processing, documentation, and reporting of serious adverse event information from clinical trials, investigator trials and post-marketing sources2. Reviewing and approving adverse events reports from clinical sources in accordance with WHO-ICH guidelines, GVP and the appropriate regulatory agencies.3. Develop and implement SOPs and other controlled documents to support investigational and marketed product safety surveillance4. Manage and conduct ongoing safety surveillance and oversee the evolving safety profiles for all company products; identify and analyze safety signals5. Monitor CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials6. Prepare new drug application safety updates, investigational new drug safety reports, investigator communications, Periodic Safety Update Reports (PSURs) and other reports as necessary7. Prepare and/or edit patient narratives for SAE safety reports and perform analyses of like events8. Participate on cross-functional product/project teams including review of safety section of protocols, investigator brochures, informed consent forms, marketing documents and other documents providing safety content9. Develop and implement Pharmacovigilance training programs for both internal and external use10. Set up and utilize appropriate databases, tracking tools11. Prepare for regulatory inspections and audit Show less • Manage interdisciplinary clinical research projects, as Project Manager, leading the clinical team to ensure on-time, on-budget performance• Supervise, train, and mentor Clinical Research staff• Approve investigator study budgets and contracts• Review and approve regulatory and administrative documents from investigatorsites• Review and develop protocols• Review and approve Case Report Forms (CRFs)• Plan, coordinate, and present at Investigators' Meetings• Participate in proposal meetings with potential clients• Review Serious Adverse Event (SAE) reports• Review and approve monthly client invoices• Prepare project management reports for clients, project personnel• Review and approve monitoring trip reports• Review Tables and Listings generated from study data• Author Clinical Study Reports• Train CRAs on monitoring, internal procedures, and query resolution• Mentor Senior CRAs on project management procedures and policiesIn addition:Development of SOP-s and work instructions for the department of clinical trials;Implementation of SOP-s at STP (standard enterprise);Preparation and participation in the audit ISO 9001.In addition:Participation in the design of primary and secondary packaging of the new product;Participation in the development of the new trade name of the product;Participation in the development and design of the site of a new product;Development and maintenance of a new product website (www.trekrezan.ru);New Website SEO product (www.trekrezan.ru). Show less
QPPV
Feb 2015 - nowClinical Project Manager
Sept 2014 - now
Licenses & Certifications

Drug safety and pharmacovigilance
Federal State Institution Scientific Center for Expertise of Medical ProductsFeb 2015
GCP for the Professionals
Professional association medical research EVIDENCEMay 2013
Languages
- ruRussian
- enEnglish
- frFrench
- chChinese/hsk 1
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