面議(經常性薪資達4萬元或以上) 台北市中山區 工作經歷不拘 1天前
Job Distribution:
-Adequately collects and manages product safety information from all applicable sources and ensures that the Global Safety Database 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 to Competent Authorities and Suspected Unexpected Serious Adverse Reaction Line Listings 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 plans.
Qualifications:
-BS Degree in pharmacy, medical, life sciences, chemistry or similar
-Proficiency in English listening, speaking, and writing
-Experience in a PV role is plus
-Demonstrated knowledge of EU and/or domestic PV regulations and guidelines
-Relevant external pharmaceutical (professional) training with an advanced professional degree
展開 績效獎金員工團保員工生日禮金年終獎金激勵獎金