Tetyana FEDYUK

Details oriented, focused on results and quality

• Establishment of Pharmacovigilance department direction, standards and processes for ensuring compliance with all applicable laws and regulations, regulatory reporting requirements, 
• Team management: recruitment, objectives setting, annual reviews conducting, promotion,
• Financial: pre-sales activities (workload estimation, project team size composition), BID defense meetings, change order management, cost-effectiveness oversight,
• The department activities cost-quality-schedule oversight and risk management,
• Compliance activities: coordination of development and implementation process of SOPs for pharmacovigilance activities, regulatory intelligence, team trainings (onboarding and continuous), training plan development, audit and inspection participation, CAPA management,
• Medical assessment of individual case safety reports,
• Deputy QPPV.

Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine

• Obstetrics and Gynecology – Certificate of Specialization

Bogomolets National Medical University, Kyiv, Ukraine

• Doctor of Medicine Diploma