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无工作经验 -
招1人 -
英语精通 -
11-09 发布
职位描述
职位描述： Title: Drug Safety Manager & Medical ManagerCompany/Location: Antengene Corporation/Shanghai Job Type: Onsite, Full-time employee Reporting to: Director of Clinical DevelopmentEssential Duties and Responsibilities: -Review/Composing Clinical Study Protocol / CSR-Solving medical questions of the protocol-Interaction with KOL interactions, advisory boards and other events. -Prepare variety of medically-related documents and publications-Submission of medical documentation including IND, CTA, NDA-Ensure all PV activities performed according to the regulatory requirements.-Document and Execute AEs/SAEs/SUSAR/DSUR reports from investigative sites and other sources.-lead the safety database and aggregate reports to meet global regulatory compliance standards.Required Skills and Abilities: Fluent English speaking/writing Master’s degree in Clinical Medicine, oncology background preferredICH/Chinese GCP preferredSafety experience including actual experience processing AE/SAE reportsEducation/Experience Required: Degree in Clinical Medicine is required Contact: Please send your CV and cover letter to Peter.Qian@antengene.com 职能类别： 其他
联系方式
华闻大厦
公司信息
Antengene Corporation is a clinical-stage drug development company focusing on introducing mid- to late-stage drug candidates from abroad to China, bringing to China Food and Drug Administration (CFDA) approval and launching products for Chinese market Antengene's approach is to leverage global medical innovation from the U.S. and Europe coupled with Antengene's expertise in clinical development and commercialization in Chinese market to alleviate cost pressures of innovators, accelerate product entry into China, expand/defend the business interest of its partners in Chinese market and ultimately meet huge medical needs of Chinese patients.
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