Працювала в 9 компаніях 18 років 4 місяці
Медицина та Охорона здоров'я, Інше, Видавництва та Поліграфія
Senior Project Manager
CluePoints
Медицина та Охорона здоров'я
1 рік 7 місяців
10.2022 - до теперішнього часу
• It-проєкт
• Agile
Senior PV Project Manager
PrimeVigilance
Медицина та Охорона здоров'я
11 місяців
11.2021 - 10.2022
Patient Safety Project Manager
LabCorp
Медицина та Охорона здоров'я
1 рік 8 місяців
02.2020 - 10.2021
Manage customer communication for assigned projects. Represent Drug safety on projects; serve as primary point of contact for Drug safety.
Manage customer deliverables for assigned projects. Provide day-to-day customer-facing leadership at project level. Responsibilities include project planning, scope management, quality management and project financial
management.
Manage finances for assigned projects. Update financial systems, revenue recognition, project budget review, project financial analysis and change orders. Ensure financial project performance through oversight of key
performance metrics.
Develop specialist expertise and act as a Subject Matter Expert (SME) on departmental or global initiatives.
Manage start-up of new projects using standard operating procedures and
best practices, including resources request, Argus safety database set-up, testing and user access request, preparation of Safety Management Plans and Pharmacovigilance Agreements, creating study-specific adverse event and safety report templates, preparing safety jod aids, setting-up safety reporting portal for assigned projects, IMP registration in EudraVigilance.
Lead meetings with internal and external stakeholders. Provide project status updates.
Provide leadership for Drug Safety team: provide trainings, quality review, instructions and process updates. Work closely with Drug safety operational team to ensure projects are delivered in accordance with customer
expectations.
Perform Drug safety project oversight for ongoing projects, request resources update, grant/revoke user accesses, update Safety Management Plans, reporting requirements, perform adverse event reconciliation in
collaboration with Data Management team.
Actively contribute during client and internal audits for assigned project. Liaise with Quality Assurance staff in the compilation of corrective action plans. Identify, record and work
Review Trial Master Plan (TMF) plan and index for Drug safety. Conduct functional lead review of the TMF based on study triggers. Work with Drug Safety operational team on minimization of TMF backlog for large programs.
Perform other duties as assigned.
Safety and Pharmacovigilance Program Delivery Lead/Senior Safety Specialist
Syneos Health
Медицина та Охорона здоров'я
7 місяців
06.2019 - 01.2020
Safety Lead/Safety Specialist II
Syneos Health
Медицина та Охорона здоров'я
3 роки
06.2016 - 06.2019
Assumed responsibilities of safety project leader for projects which require a team of Safety Specialists. Assigned resources and timelines; reorganized daily workload based on priority. Proactively communicated to management new issues and suggested solutions; report availability to take on new assignments.
Reviewed project proposals, invoices and performance metrics; perform budget review. Prepared Safety Management and Safety Reporting Plan. Coordinated workload and status review. Managed system for receipt and tracking adverse event (AE). Processed SAEs/Pregnancies according to Standard Operating Procedures (SOPs) and project specific safety plans. Triaged SAEs/Pregnancies, evaluate AE data for completeness, accuracy and regulatory reportability. Entered data into safety database. Performed Quality Control (QC) of entered data. Coded events, medical history, concomitant medications and laboratory tests. Prepared AE narratives. Queried missing information with study monitors, investigator site personnel and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved. Participated in generation of reports to the sponsor and regulatory authorities; ensure timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Coordinated with data management staff concerning reconciliation of safety data between the clinical and safety databases. Generated reports to clients and regulatory authorities as needed. Prepared and assisted in distribution of expedited and periodic safety reports for clinical projects. Ensured correct study set-up and closure including proper documentation and archival. Performed training to investigators and other departments on AE reporting. Delivered presentations regarding safety and pharmacovigilance to internal and external customers.
Safety Specialist (Специалист по безопасности)
Pharmaceutical Product Development (PPD)
Медицина та Охорона здоров'я
4 роки 6 місяців
11.2011 - 05.2016
Подготовка и подача отчетов по безопасности в регуляторные органы и этические комиссии, внесении данных о нежелательных побочных явлениях в электронную базу данных, создание отчетов CIOMS и MedWatch в базе данных, создание и внесение запросов о дополнительной информации по нежелательных побочных явлениях в клиническую базу данных для исследователей, отправка запросов на дополнительную информацию в исследовательские центры и клиническим командам, проведение сверки клинической базы данных с базой данных по безопасности с целью исключения различий и приведение систем в соответствие, проведение тренингов для клинической команды по безопасности, а также вовлеченность в написание процедур по безопасности.
Clinical Trial Associate
Product Pharmaceutical Development (PPD)
Медицина та Охорона здоров'я
4 роки 1 місяць
10.2007 - 11.2011
Предоставление административной поддержки клинической команде, проведение отбора клинических баз для проведения исследований (физибилити), сбор необходимых документов, перевод проектных документов, помощь в подготовке, проведении и закрытии проектов, подготовка и ведение файлов исследований, помощь в организации конференций для исследователей, отправка документов в отдел по обработке данных.
Campower worker
Camp Samoset
Інше
1 рік 2 місяці
06.2006 - 08.2007
Proofreader
Freelancer
Видавництва та Поліграфія
4 місяці
01.2005 - 05.2005
Ключова інформація
Навчалась в 2 закладах
Национальный медицинский университет им. А.А. Богомольца
Фармацевтический, Фармация
Київ, 2020
Киевский национальный университет им. Т. Шевченко
Институт филологии, Перевод и переводоведение
Київ, 2008
Володіє мовами
Англійська
вільно
Італійська
базовий
Може проходити співбесіду на цій мові
Може проходити співбесіду на цій мові
Українська
рідна
Додаткова інформація
Компьютерные навыки
Windows XP, 7, MS Word 2003-2010, MS Excel 2003-2010, MS Outlook 2003-2010, PowerPoint 2003-2010, Adobe Acrobat, CASCADE and CTMS (PPD Clinical Trial Management System); electronic filing systems: Live Link, Direct Connect, eMAP; FDA Adverse Event Reporting System (AERS), Adverse Drug Event & Reaction Reporting Software (ARISg), Argus, Clinical safety databases: Oracle Remote Data Capture (RDC), Medidata Rave, eClinicalOS; Safety Tracking System (STS), Medical Dictionary for Regulatory Activities (MedDRA); training systems: Skill Soft and Learning Management System (LMS); Performance Management System and Work time reporting system (Time site).
Личные качества
Strong organizational skills, high level of responsibility, experience of work without immediate manager in the country and of work in a foreign country, experience of direct communication with the client, eager to learn and to achieve new knowledge and experience, able to work simultaneously on several projects, experienced in training others team members on ongoing processes/procedures.
Татьяна
Татьяна
Project Manager
Київ
повна зайнятість, неповна зайнятість, проектна робота
Характер роботи: віддалена робота
Оновлено 1 місяць тому