職位描述
藥品警戒臨床試驗安全臨床研究臨床數(shù)據(jù)整理藥品注冊
Responsibilities
1. Ensures accurate and time-bound reporting of safety issues to China authorities, including but not limited to SUSAR, DSUR and other serious breaches.
2. Monitor national regulation changes on pharmacovigilance (PV) and update to management in a timely manner, to ensure all safety reporting activities in compliance with China PV requirements.
3. Routine review of China requirements on safety reporting.
4. Review project-specific Safety Management Plan, to ensure all safety reporting activities are covered.
5. Liaises with Regulatory Safety Reporting and PV units.
6. Support Regulatory Department for other tasks per needs.
2. Monitor national regulation changes on pharmacovigilance (PV) and update to management in a timely manner, to ensure all safety reporting activities in compliance with China PV requirements.
3. Routine review of China requirements on safety reporting.
4. Review project-specific Safety Management Plan, to ensure all safety reporting activities are covered.
5. Liaises with Regulatory Safety Reporting and PV units.
6. Support Regulatory Department for other tasks per needs.
Qualifications
1. Bachelor's or above degree in medical, pharmacy and other life science related majors
2. At least 1 year on relevant experience of regulatory or PV.
3. Have knowledge of China regulation on PV
4. Good communication and collaborative skills.
5. Fluent in both oral and written English.
2. At least 1 year on relevant experience of regulatory or PV.
3. Have knowledge of China regulation on PV
4. Good communication and collaborative skills.
5. Fluent in both oral and written English.
工作地點
上海黃浦區(qū)騰飛元創(chuàng)大廈
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職位發(fā)布者
沙凝/人事經(jīng)理
昨日活躍立即溝通
辟埃賽醫(yī)藥科技(上海)有限公司PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of clinical drugs. PSI has 2,200+ employees and 40+ affiliates in Europe, North and South America, Asia Pacific and South Africa. PSI是一家提供全方位服務(wù)的全球臨床試驗項目承包商，為制藥和生物技術(shù)行業(yè)提供廣泛的臨床試驗服務(wù)，以幫助臨床藥物的開發(fā)。PSI在歐洲、北美和南美、亞太和南非擁有2200多名員工和40多家分支機(jī)構(gòu)。
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