] CSO (Clinical Safety Officer)
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- CSO °æ·Â °¡Àå ¼±È£, PV (pharmacovigilance) °æ·Â ¼±È£, CRA °æ·ÂÀÚ °¡´É
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Job Summary:
The Clinical Safety Officer (CSO) is accountable for the oversight of defined Pharmacovigilance tasks and safety documentation and reporting of safety events (especially Serious Adverse Events and Adverse Events of Pre-specified Monitoring) related to clinical studies within his/her organization under the leadership of the CSU head.
CSO is the primary local contact for Global Pharmacovigilance & Epidemiology (GPE) concerning Pharmacovigilance activities or matters in clinical studies.
This role is key for supervision and management of all safety issues occurring in clinical trials performed in the country. Consequently the CSO should work with the SOP/Training Manager and study teams to ensure appropriate training of the monitoring staff and with Medical Advisors for appropriate medical review of safety at country level.
All clinical studies including phase IV studies performed by the Clinical Sciences and Operations Platform in the country.
N.B. for studies contracted out by the Company, CSO activities and responsibilities will be carried out by the Clinical Research Organization.
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