Experience

AVVA Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of Medical Department, MD, Ph.D.

  • May 2012 - Present

  1. Clinical trials phase I-IV, bioequivalence. Providing expertise on clinical trials matters. Conducting of post marketing clinical trials.2. Regulatory and Pharmacovigilance Department support – Instruction for medical use review– Pharmacological safety monitoring and reporting3. Medical scientific support of company’s brands– Promotional materials review– Scientific publications review and approval. – Interaction with KOLs in the field of gastroenterology, dermatology, urology, gynecology



CRA Contract Research Organization

• Clinical Research Associate

  • Dec 2009 - May 2012

  1. Coordinating of the whole process of clinical trials:– Conducting of selection, initiation, monitoring and close-out visits of clinical trials in compliance with GCP– Management of IP distribution and using– Participating in audits– Operate as the main line of communication between sponsor and the investigator2. Medical writing (Study Protocol, IB, ICF, CRF etc.) 1. Coordinating of the whole process of clinical trials:– Conducting of selection, initiation, monitoring and close-out visits of clinical trials in compliance with GCP– Management of IP distribution and using– Participating in audits– Operate as the main line of communication between sponsor and the investigator2. Medical writing (Study Protocol, IB, ICF, CRF etc.)



Pharmaceutical Company

• Research Associate, Drug Development department

  • Sep 2008 - Dec 2009

  1. Creation and review of instructions for medical use 2. Preparation of medicine certification documents 1. Creation and review of instructions for medical use 2. Preparation of medicine certification documents