天津招聘

职位描述：
1. Provides scientific safety input into key safety deliverables related to drugs/brands including internal local deliverables (e.g., regular safety profile summary), internal global deliverables (e.g., Periodic Safety Update Reports – PSURs, or RMP) and external deliverables (e.g., investigational reports on death cases, product safety summary for licensing renewal, MIAs (Medical Impact Analysis) of CFDA batch report…).
2. Reviews safety data from various local sources and is responsible for medical assessment of individual local drug/brand safety case and ensures the collection of full follow-up information for those cases.
3. Deeply involved in the activities of Risk Management Plan per product in terms of the training, implementation with medical safety perspective.
4. Work with cross functional team including but not limited to Medical, Clinical Operation to support the activities of intensive drug safety monitoring within China. Ensure that all project plan of intensive drug safety monitoring and timelines are in concert with regulatory requirements and timelines to ensure the full compliance of related Chinese regulation.
5. Work with Development Franchise to be familiar with the company's products pipeline, contribute to the Development project from medical safety perspective.
6. Supports the communication on safety topics related to Hansoh’s drug with the local Health Authorities (CFDA)
7. Provides support as needed for licensing activities, regulatory Authorities inspections and for local project.

任职要求：
1.Medical degree，At least 2 years of clinical experience
2.High level of medical competence, with an ability to balance this with industry standards to achieve business goals
3.At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
4.Drug Development Experience 、Integrative thinking、Excellence in pharmacovigilance、Patient Benefit risk assessment 举报 分享

    豪森医药创建于1995年7月，目前已发展成为集化学、生物药物研究，医药中间体、原料药合成，制剂制造和产品销售于一体的创新型医药集团，集团本部及制造基地位于黄海之滨、风光秀丽的花果山下，是国家***评定的重点高新技术企业、中国制药工业百强企业之一，国内***的抗肿瘤和精神类药物研发和生产基地之一。“豪森”为“中国***”。

    豪森高度重视新产品研发，位于连云港本部的豪森研究院，总建筑面积35000平方米，设有化学、生物、制剂开发、工艺、药理毒理、中试等多个研发部门，是国家认定的企业技术中心，设有***博士后科研工作站、省院士工作站、生物药物高技术研究实验室等多个技术平台。公司在上海张江建有药物化学科技开发中心，在美国新泽西州建有药物情报中心和分析试验室。“十一五”以来，公司先后承担包括 “国家重大新药创制专项”、“863计划”、“国家创新基金”在内的多个重大课题，一批拥有自主知识产权的国家1.1类新药已进入临床研究，部分产品将在近年内陆续投放市场,自主创新能力居全国同行业前五强，2012年被评为“国家技术创新示范企业”。

    豪森的工厂拥有国际先进的制造和检测设备、精益的制造工艺，建立了严格的质量管理体系和与国际接轨的质量标准，部分原料药和制剂产品通过美国FDA认证，并已出口至欧美、亚洲、非洲的10多个国家和地区。

    豪森建有遍布全国的销售网络和专业化的营销团队，每年由豪森组织的各类学术活动达数百场，集团本部设有学术中心和咨询热线，为全国数以万计的临床医师提供学术交流平台，为患者提供药物咨询和产品服务。

    依托优异的产品品质、专业化的营销服务，豪森的品牌价值不断提升，市场规模不断扩大。目前，公司在抗肿瘤、精神、糖尿病、消化道及抗生素等五大领域有20多个品种进入市场销售。抗肿瘤药物“泽菲”、“普来乐”、“盖诺”，精神类药物“欧兰宁”，糖尿病药物“孚来迪”，消化道药物“瑞琪”、“瑞波特”等品种，市场份额居同品类前列。

    未来的豪森将继续秉承“责任、诚信、拼搏、创新”的经营理念，以“服务社会，营造健康”为宗旨，不断超越自我，全力打造国内一流、世界知名的制药企业。