PVPhysicanSrMgr.~SeniorDirector

面议

市辖区

刷新时间：2023-04-12

职位描述

Drug Safety and Pharmacovigilance (AD to ED level)
Reports to CMO
BioNova Pharmaceuticals (Shanghai) Limited

Job Responsibilities
The core responsibilities of Drug Safety Physician is to build-up a PV team and a PV system to support company’s clinical projects and to fulfil MAH PV requirements. The specific responsibilities include those listed below:
• Take the leadership role in clinical project by providing drug safety oversight
• Review and provision of medical opinion on various reports regarding drug safety prepared within the legal framework of pharmacovigilance
• Answer Medical Information queries
• Primary medical expert in addressing safety signal and actions for risk mitigation and management
• Primary author for the safety sections of IB, clinical study protocol, clinical study report, and eCTD safety summary documents
• Primary author and point of contact with external stake holder for DSUR
• Conduct safety signal detection on a routine basis and develop methods for risk mitigation when needed

Qualification：
• Medical Master a must, Medical Doctoral regress preferred.
• Practice in medicine and knowledge in drug development.
• Good understanding in regulatory requirements and ICH/GCP for safety reporting and pharmacovigilance
• Good baseline knowledge of scientific literature retrieval and valuation (mainly using PubMed and EMBASE)
• Self-motivated and willing to contribute to patient safety
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication skills
• Fluent in written and verbal English

其他要求

招聘人数：1人
职能类别：医学经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。