Experience

Biopharma Plasma

• Ukraine
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Deputy Medical Director

  • Mar 2021 - Present

  - Clinical lead for several projects simultaneously;- Developing study management plans and ensuring the study budget is managed proactively including scope changes;- Participate in the design, execution, and oversight of clinical trials as well as in their interpretation;- Provide mentoring and guidance to less experienced colleagues on performing site qualification, site initiation, interim monitoring, and site management activities;- Keep cross-functional communication between Regulatory Affairs, Clinical Department, external counterpart and CROs, Biostatistics, and PV.- Ensure compliance with regulatory requirements as well as applicable SOPs. Show less

• Pharmacovigilance responsible person (QPPV)

  • Feb 2020 - Present

  - organization and control of the pharmacovigilance system on the territory of Ukraine and abroad in accordance with the requirements of the current regulatory framework of Ukraine and abroad;- organization and maintenance of PSMF;- preparation RMP, PSUR, ACO;- creating SOP;- ensuring the operation of the hotline 24/7, processing case reports;- monitoring of medical literature;- preparation of training materials on pharmacovigilance (lectures, video lessons, test forms), providing training for pharmacovigilance specialists and company employees;- reviewing and approving protocols of post-registration studies on the safety of medicines. Show less

• Clinical Research Associate

  • Jul 2019 - Jun 2020



Zaporizhzhya State Medical University

• Ukraine
• Higher Education
• 1 - 100 Employee

• Senior Lecturer, PhD

  • Feb 2016 - Jul 2019

  - Total number of scientific and educational works - 122 (co-authored 2 books, 2 monographs, 3 manuals stamped by the MES/MOH, 10 patents).- Pedagogical experience - 6 years (5 of which with English-speaking students)- Preparation and realization of training webinars, lecture courses, educational video films, lab works on medical, physical, colloidal, and pharmaceutical chemistry.

• Teaching Assistant

  • Aug 2012 - Feb 2016