Pei-Ming Wu
Clinical Research Associate at Statplus Inc- Claim this Profile
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日文 Full professional proficiency
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Bio
Credentials
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藥師執照
考試院Aug, 2018- Sep, 2024 -
JLPT N1
JLPT
Experience
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Statplus Inc
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Associate
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Oct 2021 - Present
Clinical Monitoring / Site Management / Safety Reporting / Submission ●Covid-19 Vaccine - Phase II study ●Covid-19 Vaccine Questionnaire Study ●Chronic Constipation - Phase III study ●Chronic Kidney Disease - Phase IV study (only participated close out) ●Hepatocellular Carcinoma- Phase Ib/II study Clinical Monitoring / Site Management / Safety Reporting / Submission ●Covid-19 Vaccine - Phase II study ●Covid-19 Vaccine Questionnaire Study ●Chronic Constipation - Phase III study ●Chronic Kidney Disease - Phase IV study (only participated close out) ●Hepatocellular Carcinoma- Phase Ib/II study
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Shionogi & Co., Ltd
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Regulatory Affairs Specialist
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Mar 2021 - Sep 2021
1. Regulatory Affairs ● Prepare required documents and submit them for post-approval change (PAC) ● Revises package inserts (PI) complying with post-approval variation of reference country PI. ● Internally reviews PI with new product registration or post-approval variation before submission. ● Periodically reviews and revises SOPs. 2. Pharmacovigilance ● Ensures compliance of PV regulatory reporting and submissions . ● Ensures timely reporting of adverse events to headquarter as PV agreements required and completes reconciliation with headquarter. ● Provides PV education training to staff. Show less
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Clinical Pharmacist
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Oct 2018 - Aug 2020
1. Actively participated in multi-disciplinary rounds by completing daily assessment of patients’ medication regimen 2. Perform medication reconciliations to ensure appropriate prior-to-admission medications are restarted 3. Assessed medication orders for appropriateness of therapy based on drug dose, frequency, interactions, adverse effects, and other relevant monitoring concerns 4. Answered any drug-related problems from medical teams 5. Presented cases on adverse drug reactions and drug-related problems at medical conferences Show less
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Education
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2018 - 2020
國立成功大學
碩士, 臨床藥學與藥物科技研究所 -
2014 - 2018
高雄醫學大學
大學, 藥學系
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