面議(經常性薪資達4萬元或以上) 台北市中山區 2年工作經驗 5天前更新
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
展開 全勤獎金產假分紅入股員工生日禮金年終獎金