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2020-09-16发布

招聘人数:1&/Job/JobDetail/x4EBA;

40-50&/Job/JobDetail/x4E07;&/Job/JobDetail/x5143;/&/Job/JobDetail/x5E74;

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职位信息

Job Summary: The role holder provides leadership and direction in area of expertise on Pharmacovigilance (PV) including but not limited to be responsible for PV coordination and management to ensure PV inspection readiness at all times. Responsibility: Job description: 1.To set up PV work process and lead PV functional team. 2.To manage PV system and reporting for clinical trials. 3.To be responsible for Risk Mitigation Plan. 4.To coordinate PV related work globally. 5.To oversight CRO in PV area. 6.To review PV data during clinical trials and CSR. 7.To support investigators in PV area. 8.To support clinical team in PV area. 9.To complete other assigned work as one of clinical team. Qualifications: 1.Master degree or above in medicine. 2.At least 5 years PV experience, oncology/immunology area is preferred. 3.With ICH-GCP/GCP training. 4.Familiar with regulatory requirements on PV. 5.With good English skills (oral and writing). 6.With good teamwork abilities. With good computer skills.

联系方式

上班地址:金科路4560号2号楼6楼

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? 50-150&/Job/JobDetail/x4EBA;

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上海岸迈生物科技有限公司是位于上海浦东新区张江高科技园区的一家新兴的创新型国际化生物技术企业,专注于利用自主知识产权的双特异性抗体技术平台(FIT-Ig)进行创新生物药的研究和开发。FIT-Ig技术是一项新型的双特异性抗体的技术平台,该技术平台能够通过简单的分子生物学手段将两个抗体串联在一起形成双抗,该双抗同时具备了两个原始抗体的功能,拥有双重活性和产业化优势。基于FIT-Ig平台技术,岸迈生物目前拥有十几个自主开发的 First-in-class 生物大分子新药研发项目,专注于恶性肿瘤靶向治疗,肿瘤免疫,T细胞导向治疗等领域。FIT-Ig技术同时也吸引了国内外多个主流生物医药企业的关注,目前已经和包括信达生物、英国Kymab公司等在内的多家企业达成了技术与产品的合作,岸迈将通过技术授权、合作开发、共享收益等多种形式实现平台战略发展,为国内药企开发双抗药物起到了引领示范和带头作用。20179月,岸迈生物荣获2017年中国创新创业大赛(生物医药行业初创组)全国总决赛冠军。
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