北京招聘

1. Assist to edit PV related SOPs, be responsible for maintaining, update and implementation of the SOPs

1. 协助撰写、审阅和维护药物警戒相关SOP

2. Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and PV regulations.

   跟踪国家法律法规更新情况，确保公司SOP和药物警戒活动符合相关法律法规要求

3. Be responsible to collect, follow up and submit the ISCRs, report PSUR and annual report, etc

   按照法规要求，负责公司产品ICSR的收集、随访、信息上报，PSUR和年度报告的递交等事宜；

4. Be responsible for staff PV training

   制作培训材料，对公司内部和外部人员进行药物警戒培训

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. Be responsible for PV related contract review, maintain.

   负责药物警戒相关的合同审阅，维护和更新药物警戒条款

7. Be responsible for handling the inspection by FDA

   负责审计/稽查的沟通协调工作，对发现的问题进行整改

8. Regularly review on PV related partners accordingly to company 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

   就药品安全与法国总部同事进行沟通

10. Supporting other departments

支持其它部门相关工作

任职资格:

1. Master or advanced degree in clinical or pharmacy qualification, with 2+ year on relevant experience of doctor or medical affairs or PV in hospital or pharmaceutical company

   本科及以上学历，临床或药学专业，两年以上医生、医学事务或PV经验

2. Extensive knowledge of the latest technical and regulatory developments

   拥有最新的技术及政策变化等广博知识

3. Good knowledge of majored diseases and drugs

   掌握专业疾病领域及产品知识

4. Good experience in relationship and stakeholder management

   拥有与利益相关者交往的良好经验

5. Project management experience

   项目管理经验

6. 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

7. Good command of English

   良好的英文能力

8. Strong communication and interpersonal skills

   优秀的沟通及人际交往能力

9. Good problem-solving skills

   良好的问题解决能力

10. Teamwork Spirit

    团队合作精神

Besins- healthcare是一家跨国制药企业，1885年由 Abel Besins先生在法国创立,目前总部位于比利时。拥有全资子公司Macanthy、Olympian实验室和Nutrico,影响力覆盖全球120多个国家,在美国,法国,德国,俄罗斯,黎巴嫩,泰国,中国香港设有办事处,工厂位于法国和比利时。

Besins- healthcare是激素和透皮给药领域的先锋，致力于开发和在全球推广创新药物，关爱人类的生命健康。