Tamar Tkebuchava

Experience

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  PSP Pharmacy

  Dec 2010 - Sept 2012

  Pharmacist

  Communicate with patients, costumers, prescribers if necessary; Provide patient counseling and pharmaceutical care to customers. Deal with insurance paperwork; Perform administrative tasks as required and defined in the company SOPs; Fulfill customers’ prescription needs while concentrating on the accuracy of every prescription filled; Unpack and check contents and condition of incoming shipments; Control medicines storage conditions; Maintain proper records, inventory and security on all scheduled drugs; Maintain a clean, neat work area, including work counters, shelves, and the customer counter to present a professional, sanitary, organized image to customers; Maintain all equipment (e.g., computers, printers, and cash registers) to ensure it remains in working condition. Show less

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  Ministry of Labour, Health and Social Affairs of Georgia

  Sept 2012 - Oct 2013

  Intern
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  ADVERTISING COMPANY “POTTERS”

  Aug 2013 - Feb 2014

  Social Media Administrator
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  Ministry of Labour, Health and Social Affairs of Georgia

  Jul 2014 - Jun 2016

  Senior Specialist
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  WORLD MEDICINE LIMITED

  Jul 2016 - Jan 2020

  Assistant of Drug Registration Manager

  - Preparation of the submission packages for the national registrations, renewals, variations of the pharmaceutical product; Gap-analysis of the documentation, compiling dossier according to Georgian legislation, arranging translations and various authentications of the administrative documentation; Submission to the regulatory agency; Communication with the Health Authority; Maintain system for tracking changes in documents submitted to the agency; Support with technical tasks such as keeping various trackers up to date. Monitor approved procedures, receive registration certificates; Cooperation with the company financial department to arrange payment for the registration and authentication procedures. Show less

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  PharmaLex

  Jan 2020 - Mar 2023

  Senior Regulatory Affairs Specialist

  Projects include:- Responsible for procedures and documents. Renewal planning, preparation, ordering of documents (from medical department, pharmacovigilance department, CMC department, CPP requests from various Health Authorities), arrange authentication procedures (CPP Embassy legalization, statements notarization/legalization) and translation, invoice tracking, declaration signing, dispatch, supporting manager with deficiency letters, create, delegate and track tasks in the system, upload/archive documents in the system, send approved documents to the manufacturing site after approval.- Support with routine screening of new marketing authorization applications in selected EU countries. - Supporting local regulatory personnel and the product team members (CMC, operational specialist) with administrative documents (cover letters, declaration, statements, application forms) which need either signature/stamp or further authentication/legalization. Supporting with the CPP requests worldwide. Request CPPs from MHRA and FDA.- Marketing Authorisation Transfer: Assist the project managers, support with preparation of documents within the framework of the project in various counties. Organization of kick-off meetings (presentation, meeting minutes) and follow-up meetings (meeting minutes) between transferor and transferee (client); Lead the preparation of the submission package in 5 EU countries. Plan timelines and workflow for specific county. Prepare and compile submission package. Support with technical tasks such as keeping various trackers up to date.- Lead the preparation of the submission package for the national registration of the pharmaceutical product in Georgia. Organization of meetings with the client. Gap-analysis of the documentation, compiling dossier according to Georgian legislation, arranging and check of translations of various documents, providing regulatory intelligence to client, dealing with the deficiency letters. Show less