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Female, 47 years, born on 29 October 1978
Moscow, not willing to relocate, prepared for business trips
Medical Director, Medical Manager, Head of Therapeutical Area, Head of Clinical Operations
Specializations:
- Sales manager, account manager
Employment type: full time
Work experience 22 years 8 months
June 2023 — currently
3 years
Roche UK
Medicine, Pharmaceuticals, Pharmacies... Show more
Associate Safety Medical Director, Portfolio Clinical Safety
- Demonstrated robust safety expertise and leadership across the product lifecycle by successfully executing Safety scientist duties across multiple complex clinical studies (phase I-III trials, including dose-optimization trial), at the different trial stages, e.g. ensured swift regulatory readiness for new trials by developing protocols and ICFs, materials for the CRA and Investigator training, site and patient materials, handling HA requests at the stage of Regulatory expertise, managed safety closure activities, contributing to CSRs and successful development and publication manuscripts and congress presentation.
- Led the writing of the various aggregated reports, such as PBRERs, DSUR, aCOs, SSRs (oncology portfolio)
- As a Signal Management SME for the ICI therapy oversee and medically lead proactive signal detection, prioritization, validation, and in-depth medical evaluation of new safety signals arising from all sources of information (signal detection, evaluation activities (assessed 7 signals, including a high-priority FDA and PRAC requests with the subsequent product label update and cRMP/EU RMP updates), perform downstream impact assessment, system support/issue resolution.
- Permanent safety representative of Global Incidents Management team for the investigation of the Product quality issues.
- Expert group member for the Study Management Team/ Protocol Execution Team
July 2020 — June 2023
3 years
Roche Russia
Moscow, roche.com
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IPV Business Development Project Lead
- Advanced strategic partnership between Clinical Safety and the PV Hubs, with a focus on co-creating and shaping a solution to deliver fit-for purpose and compliant scientific documentation enabling International Pharmacovigilance organization to be closer to our customers needs in a collaborative and efficient manner.
- Explored and promoted of E-Safety intelligence and insight generation projects across all PV Hubs and International Pharmacovigilance (IPV) organization
- Contributed into shaping of Drug Development module of the R&D Academy
March 2015 — May 2020
5 years 3 months
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Medical Director
- Developed of Medical Affairs in the countries (including hiring & capabilities building) and elevating it on the respectful partner level for internal and external stakeholders through building medical vision and driving medical strategy tailored to the country.
- Built a strong relationship with medical communities/ Therapeutic Area Experts in Russia and EAEU/ CIS and other non-CIS countries, scientific professional Associations and Patient Organizations in the countries, cross-countries experience sharing.
- Acted as Medical Director in Ukraine (6 m in 2018) – to sustained the people resources with the focus on driver role of Medical department and recognition as a trustful partner in execution of Affiliate strategy. It covers people management, full scope of medical affairs, regulatory, clinOps and PV activities.
- Shaped clinical trial market in Kazakhstan through building local infrastructure necessary for running CT (insurance, biosamples exportation, non-registered product importation, etc.) and launch of several international programs. Roche KZ is treated as an expert in CT field by Regulatory Bodies.
- Implemented of “Direct markets project” (AM, AZ, UZ, MG, MD): proper set up and oversight of PV, regulatory and medical functions in small countries with no Roche local market presence, maintenance of effective cooperation level with external stakeholders including scientific community.
- Drove the implementation and development of concept of personalized healthcare and digital transformation:
- AI in Rare Diseases and Oncology, development of technical solutions/platforms for HCPs and patient engagement
- Assessed local markets opportunities in collaborating with start-ups/innovation labs (gamification, block-chain, chat bots opportunities)
- Managed of “resources optimization project” in the countries: set up PV Hub for all CIS and Caucasus countries, Quality Management System with ex-countries LQRs, Regulatory Hub for EAEU.
- Passed of 8 GCP & GVP audits across CIS countries in 2014, GCP audit and 2 GMP audits in Ukraine in 2018.
June 2014 — February 2015
9 months
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Lead Medical Manager
(Central Asia, Caucasus, Eastern Europe)
Countries: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Ukraine, Kyrgyzstan, Turkmenistan, Uzbekistan
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Responsibilities:
* Drive the development of country medical strategy, contribution into annual brand and launch planning.
* Establishment of strong relationship with medical communities in the countries and supporting affiliates in organization of non-promotional events.
* Lead the CCE Medical Network with the objective to contribute to the business development of the medical management aspects, constant coaching, mentoring and motivation of medical staff.
* Ensure proper set up, implementation and maintenance of local medical information and PV processes in the affiliates, development and execution of GMA/PA clinical programs preparation to the GCP/GVP audits, conduction and CAPA remediation.
February 2012 — May 2014
2 years 4 months
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Lead Clinical Study Manager
Russia Management Center
Azerbaijan, Belarus, Georgia, Kazakhstan, Ukraine, Kyrgyzstan, Turkmenistan, Uzbekistan
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Responsibilities:
* Development of clinical trials infrastructure in countries, including regulatory, insurance, IMP management, Vendor selection, contracting and oversight, elaboration of counties capabilities (protocol writing, medical monitoring, publication preparation, establishment of steering committee).
* Drive clinical trials planning and allocation to the countries, contribution into annual brand and launch planning, preparation and participation in country business review.
* Management of Clinical budgets in countries in line with agreed priorities the relevant contracts and budgets.
July 2007 — January 2012
4 years 7 months
MSD Pharmaceuticals LLC
Clinical Project Manager
* 1. MSD Pharmaceuticals LLC, Moscow (legacy Schering-Plough) Responsibilities:
Execution of global clinical trials in Russian Federation, i.e. management of different aspects of trials from study feasibility, oversight of CRO, to closure of the trial and preparation of clinical study report
December 2003 — July 2007
3 years 8 months
PAREXEL International Rus
Russia
Head of Start up group, Clinical Lead
Responsibilities:
* Leading Start-up group with the focus on rapid activation of clinical trials (site feasibility and selection, local ICF development, study documents submission and approval by ECs/Health Authority, IMP release, Import/Export license management)
* Audit preparation and follow up, co-monitoring with trainee, Sponsor visits
Clinical Research Associate
* Carried out a range of activities to provide grounds for conducting clinical trials at the local level
September 2003 — November 2003
3 months
Emergency Research institute
Cardiologist
Treatment of patient with cardiovascular diseases, prevention of emergent situation, treatment plan development.
Skills
Skill proficiency levels
About me
Audit, Medical Affairs, launch preparation, insight management, iMSLs support, clinical programs preparation, implementation and maintenance of local medical information and PV processes, CAPA, Clinical Trials, e. management, local ICF development, Audit preparation, medical monitoring, publication preparation, clinical trials planning, Budgets & Budgeting, Cardiology, Clinical Operations, Clinical Research, Compliance, GCP, Management and development of different functional groups/divisions, Managerial Skills > People Management, Medical, Neurology, Oncology, Pharmacovigilance, Presentation Skills, Project Management, Strategic Planning, Virology, countries experience, development of technical solutions/platforms, leadership support, medical management, launch planning, IMP management
Higher education
2003
Higher education
Research Scientific Emergency Institute
Post-infarction department, Cardiologist
2001
Higher education
Moscow Medical Academy
Medical Doctor
Languages
Tests, examinations
2013
Ministry of Economy and Social Development
Ministry of Economy and Social Development, occupational retraining
Citizenship, travel time to work
Citizenship: Russia
Permission to work: Russia
Desired travel time to work: Doesn't matter
