Ihor Turkevych M. D.

WORK HISTORY

EDUCATION

ABOUT IHOR TURKEVYCH M. D.

Colleagues,\"American Society of Pharmacovigilance Physicians\" invites you to be valuable member of our organization. You can join with this link: AmericanPV.org/(click “Join” in the upper right corner). Please share it with all of your friends-Ihor18+ years of clinical experience (Oncology) 9+ years in the pharmaceutical industry. Drug Safety Physician. Therapeutic Areas : Oncology, Pulmonology, Pregnancy cases, DM and safety in Phases I to IV. US Medical License Examinations\' Certified Medical Doctor.Drug Safety pharmaceutical physician with expertise in all aspects of Drug Safety/Pharmacovigilance SUSAR review and Analysis of Similar Events writing as well as FDA and EMA submissions with 7 years experience drawn from medical review and Pharmacovigilance, clinical research, and academic research and analysis. Expertly compile and analyze medical data to ensure accurate reports, plans for patient care, and submissions to sponsors/regulatory bodies. Confidently communicate across organizational levels and lead diverse teams to optimal performance Demonstrate extensive knowledge of US and ICH safety reporting regulations as well as understanding of IND safety reports, 21 CFR part 11, GCP, GLP, and HIPPA guidelines. Possess fundamental knowledge of drug development process, clinical trial process, risk management, signal detection and clinical development plans. Effectively utilize MeDRA and WHO Drug dictionaries. Confidently communicate across organizational levels and lead diverse teams to optimal performance. Areas of Knowledge: Drug Safety and Drug Development Adverse Event (AE) and Serious Adverse Event (SAE) Reports MedDRA Coding Case Narratives CIOMS Line Listing Signal Detection FDA and ICH Guidelines Quality Control Clinical Interviews Data Analysis ARGUS Safety Database PSUR and SUSAR Reporting Risk Management Analysis of Similar Event FDA and EMA submissions Software Proficiencies: SciFinder MS Office Pages Numbers