Barbara Tompos
Budapest
Summary
Dear Recruitment Team, I am Barbara Tompos, I work in the pharma industry and I collected 5+ years of experience in this field (regulatory and pharmacovigilance area). I work as a team leader since Mar-2023 and I really enjoy my new role. During my work I focus on the client's satisfaction, time management and proper communication. I think that assertive communication is very important, I am very active and initiative member of the client meetings. I have a problem solving perspective and I am very reliable. Lately I received some recognitions for my job in my new role as well. The reason why I am searching for new opportunities is because I would like to acquire a significant increase in my compensation package.
Overview
6
6
years of professional experience
Work History
Team Lead
Cognizant Technology Solutions
03.2023 - Current
- Supervising and quality controlling the compilation, maintenance and updates of Regulatory Documentation and associated data in the client regulatory database system
- Managing and mentoring a team of 7 people
- Understanding client expectations, taking part in weekly meetings with the clients and Vendor Manager reporting to them about the project's tasks
- Creating monthly utilization statistics in excel
- Assuring to meet the requirements regarding the client's KPI and metrics, assuring they always stay above the required level
- Taking part proactively in internal and external audits
- Handling SWIs, SOPs, CAPA documents, deviations, and other formal documents, making sure they are updated, approved and kept in the right place in the database
- Training new team members
- Evaluated employee skills and knowledge regularly
- Managing new joiner and exit related tasks in close contact with HR
Regulatory Officer
Cognizant Technology Solutions
06.2020 - 02.2023
- Archiving and linking the different regulatory documents (Local Product Information, Company Core Data Sheet, Summary of Product Characteristics) in the relevant corporate tracking database (CPD3, BIRDS, CTMS portal)
- Handling medicinal products in xEVMPD (inserting, updating, invalidating medicinal products, updating data manually in the system), sending updated SmPCs to EMA, tracking EVWEB, modifying xmls
- Reporting tasks: running queries to check if database contains all necessary documents and data; providing reports (such as compliance report-PSUR,DSUR) to other teams
- Ensuring database entries are complete and accurate
- Comparing data of regulatory documents to the database, taking care that they meet the corporate’s requirements and regulatory rules (CNO form, LPI)
Product Developer
BiotechUSA Kft.
01.2020 - 05.2020
- taking part in the development of the products both on theoretical and practical field, creating new recipes, changing previous recipes
- laboratory work, sensory evaluation of the products
- keeping track of all the competitors, brands, and the overall sport supplement market
- up to date knowledge of the latest food regulations, food law
- examining of alternative raw materials, creating product labels and specifications
Submission and Information Specialist
Tata Consultancy Services
07.2019 - 12.2019
- Handling electronic submissions of new and existing regulatory applications
- Ensuring documents are compliant with client standards and ICH guidelines
- Reviewing and formating cmc's, using PDF editing tools including Adobe Acrobat
- Ensuring overall submission quality
Medical Safety Specialist
Tata Consultancy Services
03.2018 - 06.2019
- Case processing, what includes entering complete information from the safety report , reporting adverse events and the coding the products
- Data capturing of adverse event reports from clinical trials, post-marketing studies, spontaneous reports, market research and patient support programs
- Performing appropriate clinical assessment
- Keeping contact with other affiliates and the management
- Raising queries if needed
Education
Master of Science - Food Engineering- Biotechnology
Szent István University
Budapest12.2016
Erasmus Semester - Food Engineering
Hochschule Fulda of Applied Sciences
Fulda, Germany07.2014
Bachelor of Science - Food Engineering
Corvinus University of Budapest
Budapest12.2013
Skills
- Time management
- Task assignments
- Assertive communication
- Performance Improvement
- MS Office (especially excel usage)
- Fluent english language
Languages
Hungarian
Native language
English
Upper intermediate
B2
Italian
Intermediate
B1
Timeline
Team Lead
Cognizant Technology Solutions
03.2023 - Current
Regulatory Officer
Cognizant Technology Solutions
06.2020 - 02.2023
Product Developer
BiotechUSA Kft.
01.2020 - 05.2020
Submission and Information Specialist
Tata Consultancy Services
07.2019 - 12.2019
Medical Safety Specialist
Tata Consultancy Services
03.2018 - 06.2019
Master of Science - Food Engineering- Biotechnology
Szent István University
Erasmus Semester - Food Engineering
Hochschule Fulda of Applied Sciences
Bachelor of Science - Food Engineering
Corvinus University of Budapest
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