(Sr.)Safety Scientist 上海

月薪： 1.2-2.5万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： The Safety Scientist is responsible for carrying out pharmacovigilance and risk management activities for the assigned product(s). This may include, single case processing, medical review and reporting, aggregate reporting, signal detection and evaluation, safety related activities associated with investigational drug application/new drug applications/regulatory filings, benefit risk assessment and safety risk management.The Safety Scientist supports the Safety Science Leader and may be responsible for particular aspect(s) of the overall program or a group of products. Applicable tasks are not limited to and may vary by product(s) assigned.Pharmacovigilance activities:1. Process, review, preparation and submission of individual case safety report (ICSR) from clinical trials to meet regulatory requirements.2. Perform contract review to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.3. Coordinate safety activities between Luoxin and external partners and maintain active safety oversight to ensure regulatory compliance.4. Coordinate the provision of support for third party safety agreements with PV implications and ensure the PV agreement is implemented as appropriate.5. Prepare and submit periodic safety reports in accordance with regulatory requirements.Signal detection and evaluation:1. Carry out medical review of individual case safety reports (ICSRs), if assigned for the product.2. Reporting of potential single case signal or clusters of similar events detected in case processing, as applicable.3. Conduct/support signal detection and evaluation4. Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.5. Collaborates with external provider representatives in routine signal management activities.Risk management activities:1. Develop safety profile of the assigned product.2. Support the preparation and maintenance of Risk Management Plan.3. Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents.4. Contribute to regulatory agency submissions (IND applications, NDAs, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages.Qualification：1. Prior industry experience in drug safety, clinical development or medical affairs.2. Good knowledge of pharmacovigilance regulatory requirements.3. Good knowledge of pharmacovigilance practices and tools (e.g. databases, signal detection tools, MedDRA)4. Ability to evaluate, interpret and present scientific data.5. Team player with ability to function in a multi-disciplinary environment6. Good written and oral communication skill in both Chinese and English in the negotiation, presentation, and authoring process with relevant cross function team, medical experts, as well as regulatory reviewers7. Sufficient knowledge of business process, regulatory, and compliance related to drug development8. Attention to detail.9. Good computing/IT skills. 职能类别： 临床研究员

联系方式

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公司信息

罗欣生物科技（上海）有限公司是山东罗欣药业集团股份有限公司（在香港上市的公司）的全资子公司，是罗欣集团为了满足日益增长的研发需要，于2014年6月在上海成立的研发公司。罗欣生物科技将定向承担母公司的研发业务，包括化学药和生物药。我们需要各类研发和管理人才，在此，我们真诚邀请您的加盟，共同创造新的辉煌！ 罗欣集团是集药品研发、生产、贸易融为一体的大型医药企业集团，由山东罗欣药业股份有限公司、山东明欣医药有限公司、山东罗盛医药有限公司等十几家公司组成。企业被国家商务部评为“aaa①”级诚信企业，“罗欣”商标被国家工商总局商标局认定为“中国著名商标”，多次被国家、省、市授予“aaa级信誉企业”、“守合同重信用企业”、“文明单位”、“医药行业先进单位”等荣誉称号。 山东罗欣药业集团股份有限公司为集团骨干企业，是由山东罗欣制药厂改制重组、罗欣医药集团有限公司控股、联合沈阳药科大学等共11家发起人共同设立的股份制公司，是严格按照现代企业制度和国家gmp要求组建的制药企业。公司股份于2005年12月在香港h股挂牌上市，自2006年开始公司连续进入中国制药工业百强企业和中国十大最具成长力药企，是国家重点高新技术企业。目前，公司建有粉针剂、冻干粉针剂、大容量注射剂、小容量注射剂、固体制剂、化学原料药等三十多条生产线，已有十几个剂型、200多个产品规格上市，其中***新药46个。公司可年产粉针剂10亿支，冻干粉针剂3亿支，大容量注射剂4亿瓶，小容量注射剂5亿支，片剂25亿片，胶囊剂20亿粒，颗粒剂3亿袋，干混悬剂8000万袋，化学原料药300吨。 最新动态：山东罗欣药业集团股份有限公司在2014中国化学制药行业工业企业综合实力百强中位列第23位。产品——注射用兰索拉唑（商品名/商标名：兰川）被授予“2014中国化学制药行业消化系统类优秀产品品牌“。

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