Medical safety lead- Radioligand therapy
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Physician with 8 years of exceptional experience in pharmacovigilance or drug safety. At Novartis, I am currently working as a member of medical safety team for radioligand therapies and imaging agents (Nuclear medicine-Precision oncology).
Experience in coordinating and preparing responses to Health Authority/ CPO queries on assigned drugs. Author/coauthor of regulatory-compliant, competitive, and up-to-date Health Authority submission documents (PSUR, DSUR, USPR, RMP, CDS). Experience in review of clinical documents (Investigator Brochures, protocols, clinical study reports. Working in a worldwide (multi-cultural) setting with cross-functional teams. Capable of training/coaching case processors in ARGUS/Medical related queries, as well as coaching and technical training to new team members.
Physician with 8 years of exceptional experience in pharmacovigilance or drug safety. At Novartis, I am currently working as a member of medical safety team for radioligand therapies and imaging agents (Nuclear medicine-Precision oncology).
Experience in coordinating and preparing responses to Health Authority/ CPO queries on assigned drugs. Author/coauthor of regulatory-compliant, competitive, and up-to-date Health Authority submission documents (PSUR, DSUR, USPR, RMP, CDS). Experience in review of clinical documents (Investigator Brochures, protocols, clinical study reports. Working in a worldwide (multi-cultural) setting with cross-functional teams. Capable of training/coaching case processors in ARGUS/Medical related queries, as well as coaching and technical training to new team members.
Medical Doctor from Zaporozhye State Medical University, Ukraine, Europe (batch 2006-2012).