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MG-知名藥商 徵 Drug Safety Specialist (近行天宮站)
面試心得
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企業名
新加坡商立可人事顧問有限公司
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工作地點
台北市中山區
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薪資
時薪202~290元
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工作內容
Job Distribution:
-Adequately collects and manages product safety information from all applicable sources and ensures that the Global Safety Database (GSD) is used to record source information accurately, timely and completely at affiliate level. Contributes to maintaining effective oversight of local / regional / global suppliers that manage this activity permanently or temporarily.
-Distributes and/or submits ICSRs to relevant destinations, as applicable.
-Periodically reviews local literature, as applicable.
-Distributes / submits aggregate reports such as Periodic Safety Update Reports (PSURs) to Competent Authorities (CAs) and Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings (LLs) to Investigators, as applicable. Manages local translations and creation of annexes and cover letters where required.
-Support to adequate and timely implementation of additional Risk Minimization Measures, as applicable.
-Support to the Follow-up Report or Assessment for L-RMP, which is prepared in accordance with local regulatory requirements and submitted to local Health Authorities, as applicable.
-Support timely and compliant management of locally required post-authorization studies, as applicable.
-Contributes to effective PV business continuity arrangements and PV-related third party life-cycle management.
-Contributes to PV system audits, inspections and management of non-conformances and Corrective Actions and Preventive Action (CAPA) plans.
Qualifications:
-BS Degree in pharmacy, medical, life sciences, chemistry or similar
-Proficiency in English listening, speaking, and writing
-Experience in a PV role
-Demonstrated knowledge of EU and/or domestic PV regulations and guidelines
-Relevant external pharmaceutical (professional) training with an advanced professional degree
新加坡商立可人事顧問有限公司-使用1111轉職專區
https://central1111.com.tw/turn/