南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京医药技术研发管理人员招聘

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)制药有限公司(以下简称“萌蒂中国制药”)自1993年成立以来,始终专注于在疼痛领域的规范化治疗理念的推广和产品研发与生产。
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