药物安全经理/高级药物安全经理
萌蒂(中国)制药有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2018-04-14
- 工作地点:北京-朝阳区
- 工作经验:8-9年经验
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:2.5-3万/月
- 职位类别:医药技术研发管理人员
职位描述
? Oversee PV system to ensure the compliance with relevant regulations and common practices.
? Build and update PV SOPs according to latest requests by regulations or Health Authorities.
? Ensure appropriate PV agreements are in place with relevant business partners.
? Response to Health Authorities and HCPs for urgent safety issues and drug safety concerns.
? Perform ongoing review of emerging safety data from various sources and provide medical safety oversight in the context of medical review process.
? Work with operation teams to develop and continuously maintain and improve effective systems to ensure single cases fulfill the requirements for signal detection.
? Responsible for safety assessment activities and lead PV risk management local process.
? Drug risk evaluation and solicited data signaling.
? Ensure appropriate clinical safety risk communication and escalation to China Medical Director, EU QPPV and EU Vigilance Risk Management Team.
? Liaise with internal and external experts/KOLs to obtain specialized medical expertise as appropriate.
? Provide high quality and consistent input to support clinical development and life cycle management.
? Perform effective due diligence activities as appropriate.
任职资格:
? MD degree or equivalent (e.g., DO or MB) required.
? Two years or more of clinical experience as well as at least 5 years of pharmacovigilance experience, or overall equivalent experience profile.
? Appropriate experience with Regulatory Agency and KOL interactions.
? Knowledge of relevant concepts in data management and systems, epidemiology and statistics.
? Effectively communicates in written and spoken English.
? Excellent analytical and problem solving skills.
Provide effective and relevant review of complex documents.
职能类别: 医药技术研发管理人员
公司介绍
萌蒂中国制药目前在华拥有1300多位员工,业务遍布300多个城市。在北京拥有设备先进、专业生产麻醉和精神类药品的工厂。
通过20多年的不懈努力,萌蒂中国制药已成为中国癌痛领域的领导者,并引领镇痛领域。
多年来,我们一直坚持为提高人类的生活质量和健康水平而奋斗,“健康生活,品质人生”是我们的企业愿景;关爱生命,回馈社会是我们的社会责任;创新的天赋,以患者为核心的理念以及企业家精神是我们血液中的 DNA。
2018年3月,由国家卫生健康委员会扶贫办指导,《健康报》社、中国人口福利基金会健康报公益基金主办,萌蒂中国制药支持的“康萌大病救助计划”公益项目在北京正式启动,成为社会力量参与健康扶贫、大病救助的典范。
未来,萌蒂中国制药将继续深耕疼痛管理领域,同时将业务进一步拓展至抗呕吐、移植与免疫治疗、肿瘤、呼吸系统、健康消费品等全新领域,不断提供创新的产品,积极履行企业社会责任,为实现“健康生活,品质人生”的企业愿景而不懈努力。
联系方式
- 公司地址:北京市朝阳区东三环中路1号环球金融中心西楼18层 (邮编:100022)
- 电话:13811131800