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

Act as the Project Lead for client engagement and pimary point of contact for escalation and resolution of issues. Develop and maintain project plans, project risk boards and action logs and ensure timely status updates. Identify and mitigate project-related risks and issues. Ensure all project milestones are delivered in a timely manner with highest quality. Lead client meetings (Project planning, Kick Off, Specifications Review, Risk Review meetings etc.). Involved in validation meetings and process with the clients including application/software, data sources validation and user acceptance testing, API, systems integration and automation. Request resources, manage study assignment and timelines. Involved in risk-based quality management (RBQM) analytics projects as well as experimental (artificial intelligence (AI)/machine learning (ML)) projects. Perform monthly budget review and reconciliation, timesheet review and approval for assigned project team. Support clients with customization of matrix of roles and training plans. Work with 5 pharma companies on various projects simultaneously.
• It-проєкт
• Agile

Senior PV Project Manager

PrimeVigilance

Медицина та Охорона здоров'я

11 місяців

11.2021 - 10.2022

Safety set-up of the project including budget review, safety management plan preparation, regulatory reporting requirements, safety reporting forms and guidelines. Safety database set-up and legacy cases migration. Safety mailbox, dedicated fax number and client repository area set up. EudraVigilance set-up and XEVMPD initial entries and updates. Led Kick-off Meeting and regular meetings with the clients. Prepared regular operational reports and invoices. Resource requesting for the projects. Reviewed client’s standard operating procedures, protocol and protocol amendments for safety, Safety Data Exchange Agreements. Prepared SAE reconciliation plan for the client where contracted. Oversighted quality and compliance for assigned projects, processing and reporting of individual case safety reports and safety reports within reporting timelines. Collaborated with the third party vendor for proper FDA set-up and submission process. Oversighted development of aggregate safety reports for client company products, signal detection process and literature screening set up. Acted as the PV Project Manager for 7 clients.

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

Acted as a Safety Lead for multiple studies and as a Portfolio Lead for assigned programs. Provided project oversight for safety activities. Performed monthly financial performance and budget review. Developed Safety Management and Safety Reporting Plans. Provided pharmacovigilance metrics and compliance reports to the sponsors. Mentored new safety team members on study-specific tasks. Participated in audits and inspections and ensured inspection readiness at all times. Performed SAE receipt and notification to the sponsor, case processing including data entry and narrative writing, generation of draft and final reports, query requests to the sites and quality control for other safety specialists. Performed quality check of submission packages to Regulatory Authorities, Ethic Committees and investigators. Ensured Argus safety database was updated with the latest versions of MedDRA and WHO. Performed regulatory intelligence review for assigned countries. Performed training compliance review for assigned safety team. Involved in SAE reconciliation between clinical and safety database. Attended Bid Defence, Kick-off Meetings and Investigator Meetings as a Safety Lead.

Safety Lead/Safety Specialist II

Syneos Health

Медицина та Охорона здоров'я

3 роки

06.2016 - 06.2019

Interface between Company, sponsors, vendors and other departments in the area of safety and pharmacovigilance.
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

Responsible for full cycle of safety reporting, starting from receipt of Serious Adverse Event (SAE) form from site and up to submission of the report to sponsor, submission of expedited safety reports (SUSARs) and periodic safety reports (DSUR and Six-Monthly Safety reports) to Regulatory Authorities, Ethics Committees and investigators, SAE reconciliation between Clinical database and Safety database, follow-up with sites on outstanding queries.

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

Responsible for providing project administrative support to Clinical team, conduct of feasibility, collection of mandatory essential documents, preparation of Regulatory Compliance Packages, translation of project-specific documentation, support in trial set-up, monitoring, tracking and close out, preparation and maintenance of country and investigator files, assistance in organization of investigator meetings, sending paper Case Report Forms (CRF) to Data management.

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

Responsible for cooking meals, preparing food, dishwashing, table setting, keeping the dining hall running smoothly, ensure the work is done efficiently and on-time, working as a part of an international team from all over the world and being a support to a team lead in the kitchen.

Proofreader

Freelancer

Видавництва та Поліграфія

4 місяці

01.2005 - 05.2005

Reading draft versions of publications to detect and correct production errors for articles, ensure consistent accuracy by default being the last stage of typographic production before publication.

Ключова інформація

Professional with over 15 years of work experience in the field of clinical trials, both clinical and pharmacovigilance, having good communicational, team work, problem solving and work commitment skills. Always eager to learn and get new skills.

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

Project Manager

Київ

38 років

повна зайнятість, неповна зайнятість, проектна робота

Характер роботи: віддалена робота

Оновлено 1 місяць тому