上海相关职位： 验证工程师（厂房设施） QC理化仪器助理研究员 BAD副研究员/研究员(药理分析) 中试细胞培养技术员 研发QA经理 QA放行主管(制剂) 活性检测副研究员 分析方法开发及样品检测副研究员 BAD副研究员（生物活性） 副总裁特助（医药研发）
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-15
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无工作经验 -
本科 -
招1人 -
11-15 发布
职位描述
职位描述： About Position - PV Manager/ Sr. ManagerDepartment:Clinical DevelopmentEmployment Status:Full time employeeWorking Location:Shanghai, ChinaOverviewAccountable for overarching pharmacovigilance activities for ongoing and upcoming oncology clinical trials in international regions and China. Ensure CStone to comply with company policies and fulfill China and other countries health authority requirements, reach the target of mitigating risks and help all patients exposed to CStone drugs.ResponsibilitiesAccountable for pharmacovigilance activities for assigned clinical trialsReview all adverse events received from CROs for ongoing clinical trials and process them in safety database.Working with CRO to ensure reporting compliance with regulatory agency reporting requirements worldwide.Responsible for draft DRMP, DSUR, analysis of similar events (AOSE) or periodic safety summary report when needed.Perform medical review from safety perspective for individual SAE from clinical trials, including provide company comments for causality assessment against investigator’s assessment.Perform safety signal detection base on obtained safety data from clinical trials.Serve as local expert by ensuring the appropriate SOPs and guidelines are available and routinely updated. Stay abreast of regulatory updates.Provide technical level process expertise and conduct periodic assessments to ensure established processes are being followed in a consistent and timely manner.Education/QualificationMS or MD in medicine or nursing.Industry experience of which 3-5 years is relevant to pharmacovigilance/drug safety knowledgeFamiliar with hospital and clinical operations.Good verbal, written and presentation skills in English and ChineseGood communication skillsKnowledge of medical and drug terminologyKnowledge of ICH Good Clinical Practice (GCP), and other ICH guidelines related to clinical safety management and documentation.Knowledge of worldwide regulatory requirements and reporting of adverse event for investigational productsAwareness of the regulatory environment regarding Risk Management and Pharmacovigilance.Title and compensation commensurate with qualifications and experiencePersonal QualitiesProactive and organized with exceptional follow-upAnticipate/ identify problems and takes appropriate action to correctHigh degree of accuracy with attention to detailsWilling and able to learn quickly in a fast-paced environmentExcellent team player. Express different viewpoints with colleagues in a proper and constructive manner薪水面议 职能类别： 其他 其他
联系方式
张衡路1000弄
公司信息
CStone Pharmaceuticals is an innovative, research-based, biopharmaceutical company committed to the development of a new generation of therapeutic drugs. Based in both Shanghai and Suzhou, the company's leadership team consists of seasoned executives from top pharmaceutical MNCs. In July 2016, CStone announced the completion of its Series A financing, raising a total of US$150 million (about 975 million RMB). Three prestigious investment companies in the industry, Oriza Seed Venture Capital (Oriza Seed), Boyu Capital, and WuXi Healthcare Ventures (WXHV), jointly invested in the round. With an overarching commitment to meeting the most pressing needs of Chinese patients, the company's pipeline covers five therapeutic areas, including oncology, cardiovascular diseases, rheumatoid arthritis, hematology and autoimmune diseases. With immuno-oncology as CStone's core therapeutic focus, the company strives to lead Chinese research to the global market through its world class R&D team, its innovative portfolio, and an open innovation strategy.基石药业是一家创新的研发驱动型生物制药公司，致力于开发新一代的治疗性药物，创立于中国上海和苏州两地，公司的领导团队由来自国际顶尖药企的管理层成员组成。 2016年7月宣布完成A轮融资，共募集到1.5亿美元（约9.75亿人民币）资金，由三家颇具声望的投资公司参与，分别是元禾原点创业投资管理有限公司、博裕资本及毓承资本。目前，基石药业拥有肿瘤、心血管、风湿性关节炎、血液病及自身免疫病等五个治疗领域的产品线，旨在满足中国病患重大迫切的临床需求。在广受瞩目的肿瘤治疗领域，基石药业以其出色的肿瘤免疫药物为核心，凭借其世界级的研发团队，最前沿的药物研发项目，以及开放式创新的策略有望引领国内新药研发行业走向全球。
