PV QC Manager

The role holder acts as an expert on a variety of pharmacovigilance activities and quality management. The role holder establishes and executes the quality / compliance strategy to mitigate GVP risk and support license to operate, including but not limited to PV quality control activities, PV quality review to vendors / partners, PV training and quality self-assessment. The role holder leads identification, recording and resolution of GVP risks and issues, and provides analysis and trending to identify area for improvement. The role holder often acts as the first point of contact for PV related queries from stakeholders

Job Summary

Internal : all functions in China Patient Safety (Safety Operation Excellence, Safety Surveillance, Safety Enablement) , other functions include Global Patient Safety, global Compliance and Inspection Excellence, global Quality assurance, Market Authorization Holder, local Medical Affair, Regulatory Affair, China Research & Development, and etc. 内部：中国患者安全内所有相关团队，其他部门包括全球患者安全团队，全球合规与检查卓越，全球质量保证 团队，上市许可持有人，本地医学事务，政府事务，中国研发团队等  External : Service provider / Vendor for PS, License Partner, Health Authority, Industry Associations, RDPAC 外部：患者安全服务供应商，合作方,监管机构，行业协会如 RDPAC

Familiar with Pharmacovigilance laws and regulations, with required knowledge and skills to conduct PV activities 熟悉药物警戒相关法律法规和技术指导原则，具备 开展药物警戒活动所需知识和技能  Strong interpersonal and communication skills, with the ability to work effectively with stakeholders at all levels 良好的人际关系和沟通技巧，能够与各级利益相关 者有效合作  Project Management Skills 项目管理技能  Fluent oral and written English is essential 流利的英语口语和书面英语  Proficient in common office software and office equipment operation skills 熟练掌握常用办公软件和办公设备操作技巧

For Associate Manger：  At least 3 years working experience in multinational pharmaceutical company in Pharmacovigilance or Quality Management function 跨国医药公司药物警戒或质量管理方面至少 3 年工 作经验

For Manager：  At least 5 years working experience in multinational pharmaceutical company in Pharmacovigilance or Quality Management function 跨国医药公司药物警戒或质量管理方面至少 5 年工 作经验  At least 1-2 years’ experience in PV quality control or quality assurance area 药物警戒质量控制或质量保证至少 1 至 2 年工作经 验

Date Posted

16-5月-2024

Closing Date

10-8月-2024