As part of the Japan Safety organization at Amgen Astellas BioPharma （AABP）, the Japan Safety PV Sr Assoc is responsible for processing adverse event cases for local regulatory submission and advising Safety Associate on case processing triaging medical literature and measure taken information for local regulatory reporting drafting periodic safety reports escalating safety data quality issues and assisting the senior PV staff regarding a full range of safety activities.
|応募資格||■Understanding of local regulatory requirements for pharmacovigilance
■Competence in safety systems and medical coding
■Reading and written communication skills in both Japanese and English
■General understanding of industry practices and standards
■Experience with MS Word, Excel, PowerPoint, and Outlook.