非公開
・To implement appropriate Pharmacovigilance activities of Marketed Prod-ucts and Investigational Products in compliance with GVP, GPSP, GCP and relevant regulatory requirements and SOPs
・Be responsible for overall management of evaluation and reporting of do-mestic and foreign individual case reports of Marketed Products and Inves-tigational Products
・Be responsible for overall management of evaluation and reporting of do-mestic and foreign research reports and measures taken overseas
・Provide safety information to relevant parties
・Implement Pharmacovigilance Agreements
・Maintain PV Awareness and Training
・Ensure PV Audit and Inspection Readiness
・Plan, process and report Aggregate Reports to global and competent au-thorities
・Create local Risk Management Plans
・Management of GPSP related activities including handling of Specific Use-Result Survey and Reexamination
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