Shire Lead, Drug Safety, Greater China in Shanghai, China
The Lead, Drug Safety, Greater China is responsible for developing, maintaining and overseeing an efficient pharmacovigilance (PV) system and overseeing the clinical study and post-market safety function of the applicable affiliate offices in compliance with local regulations and company policies. This role will be the primary point of contact for applicable country office safety enquiries, issues and support, and will monitor the systematic collection, documentation, submission, reconciliation and timely communication of drug safety information pertinent to all local marketed products and those clinical studies with local safety responsibilities.
Responsibilities 工作职责 :
Set up, maintain and oversee a local efficient pharmacovigilance system. 建立、维护和监督当地有效的药物警戒系统。
Master local pharmacovigilance-related regulations and maintaining knowledge of them with particular reference to deviations from standard ICH / EU definitions, requirements for new changes with impact on the PV-system, and communicate accordingly. 熟悉当地药物警戒相关法规，识别其中与ICH和欧盟法规有不一致的内容及时进行交流并要求药物警戒系统相应的更新。
Collaborate with Global Drug Safety (GDS) and local cross-functional team in development and implementation of local Risk Management Plan. 通过与总部及当地跨部门同事合作制定和确保执行当地的风险管理计划。
Support local product registration and license maintenance activities. 支持产品注册以及注册证更新活动。
Communication with regulatory authorities. 与法规监管部门的沟通。
Assist with audit preparation and lead local authority pharmacovigilance inspection if required. 协助审计和负责当地监管机构稽查的准备工作。
Qualifications 职位要求 :
Bachelor degree or above, with Medical or Pharmacy background. 医学或药学背景，本科或以上学历。
Expert knowledge of China and international Pharmacovigilance regulations. 对中国及国际药物警戒相关法规有良好的专业知识。
More than 3 years of working experience in Pharmacovigilance in a multinational pharmaceutical company. 在跨国公司的药物安全部门有超过三年的工作经验。
Experience of working with quality management processes and compliance monitoring. 有质量管理和合规监督经验。
Able to independently resolve problems and conflicts. 有独立解决问题和冲突的能力。
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.