1. 隶属部门/Situation in structure 属高级医学经理直接领导 Directly lead by Senior Medical Manager
2. 职责/Mission 负责PV相关工作 Responsible for PV related work.
3. 主要工作/Main Activities 1. Collect, Document, Process and submit AEs/ADRs from any sources from China market and from clinical studies in China, as well as the ISCRs, PSUR and annual report, etc 收集,保存,处理和上报从中国市场以及临床研究机构获得的AEs/ADRs, ICSRs , 以及PSUR和年度报告的递交等事宜 2. Be responsible for literature search for safety information. 负责公司产品的安全性信息的文献检索工作 3. Assist to edit PV related SOPs, be responsible for maintaining, updating and implementation of the SOPs 协助撰写、审阅和维护药物警戒相关SOP 4. Support for staff PV internal and external training 协助开展公司内部和外部人员的药物警戒培训 5. Be responsible for PV documents management and archive 负责公司药物警戒各类文件的管理归档 6. Support for PV related contract review 、maintaining and renewal 协助药物警戒相的合同的审阅,维护和药物警戒条款更新 7. Support to coordinate with the audit and inspection from authorities if any 协助管沟通协调来自有关部门的审计/稽查 8. Regularly review on PV related work with outsourced business partners according to company’s internal process and regulations 根据公司程序和部门规定,定期与商业合作伙伴进行工作核对 9. In time communication with HQ PV departments 就药品安全与总部进行沟通 10. Supporting other departments 支持其它部门相关工作
4. 能力要求/Competence 1. Bachelor or advanced degree in clinical or pharmacy qualification, with 1 year on relevant experience of PV in pharmaceutical company 本科及以上学历,临床或药学专业,1年以上PV经验 2. Willing to learn and passionate on work, think creatively and do proactively 愿意学习、乐于工作,积极思考、主动进取 3. Responsible, patient and cautious 认真负责、耐心细致 4. Good experience in relationship and stakeholder management 拥有与利益相关者交往的良好经验 5. Advanced skill level with Microsoft Office, esp. PPT and Excel 熟练的办公软件操作技能,尤其是PPT和Excel 6. Good command of English 良好的英文能力 7. Strong communication and interpersonal skills 优秀的沟通及人际交往能力 8. Good problem-solving skills