Skills

  • регуляторный менеджмент
  • сертификация
  • лицензирование
  • GMP
  • фармацевтика
  • Медицина

Experience

Ольга Бондарь

Work experience
  • Management of Medical and Regulatory Structure Ukraine and CIS with main responsibilities:
  • regulatory: registration, renewal, variations for drugs and food supplements,
  • GMP confirmation manufacturers in PIC/S countries,
  • GMP inspections manufacturers in non PIC/S countries,
  • relationship with the State Inspection, the Ministry of Health and the State Expert Center,
  • connecting with Head office, complete the dossiers,
  • рandling and processing requests for obtaining regulatory documents (dossiers, certificates, letters, permissions, licenses, etc.);
  • develop, correction and approval Artworks;
  • сollecting and completing sets of documents for submitting to Regulatory bodies or service providers;Interacting between internal customers and service providers and monitoring the status of open document requests;
  • managing regulatory documents expiry dates and initiating renewal of documents within the assigned scope of documents groups (assure and maintain permanent availability);
  • Problems analyzing and proposing solutions within the assigned area of responsibility
  • Pharmacovigilance: Ukrainian Qualified Person for Pharmacovigilance; Ukraine with regards to patients’ or public health, covered by the pharmacovigilance system, the responsibilities of the QPPV should include the requirements of Ukrainian GVP
  • establish and maintain a system of collection, assessment and submission of information on adverse reactions, lack of efficacy, AEFI, other data relating to safety and efficacy
  • ensure substantiated assessment of any information on risks relating to medicinal products, as regards the impact on patients’ or public health
  • oversight of local signal detection results
  • having an overview of medicinal product safety profiles and any emerging safety concerns;
  • having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products;
  • having awareness over the content of risk management plans and their submission in Ukraine, and of risk minimisation measures;
  • ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;
  • ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Ukraine
  • Quality: verification and matching of CoA;
  • communication with the State Inspectorate and distributors on quality issues;
  • placement of mock-ups in the system of the State Inspection
  • Promotion: review promotion materials

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