药物警戒-上市后

公司部门: Clinical Development

工作地点:北京

发布日期:2022-01-13

招聘人数:1人

职位类型:生物制药/医疗器械

职位描述:

主要职能:

Key Objectives/Deliverables:

1. 参与上市后药物警戒体系的搭建和维护,以保证其高效并合规;

2. 保证上市后药物警戒团队工作的质量与合规性,使其能够充分符合相应法规和公司SOP的要求;

3. 对各种来源的产品安全性信息进行收集、评价和处理的管理,按照相应法规要求及公司SOP,在时限内向监管部门进行个例报告快速递交和PSUR、年度报告等安全性汇总报告的递交;

4. 参与不良事件特别是一些重大不良事件如死亡、群体不良事件的调查和处理;

5. 参与各类安全性汇总报告(如 PSUR、年度总结报告)的撰写工作,确保按照法规要求时限递交;

6. 参与产品再注册等产品生命周期管理相关工作;

7. 参与公司内部PV相关合规管理,保证公司在医学市场项目等各类项目中的药物警戒合规;

8. 参与安全信号检测和风险管理;

9. 与药品监管部门进行良好的沟通及合作;

10. 在药物警戒或其他监管机构检查期间,参与向监督管理机构检查人员解释和阐述药物警戒工作内容;

11. 为相关部门提供药物警戒培训;

12. 参与管理与各种外部合作伙伴起草和签署药物警戒协议;

13. 管理药物警戒文件的编制、修订及存档,药物警戒所有记录及资料的维护与更新;

14. 完成上级主管交代的其他工作。

1. Contributes on the establishment and improvement of a local PV system, to ensure its more efficient and keep PV compliance;

2. Assures compliance and quality of post-marketing PV activities, which fully comply with the corresponding regulatory requirements and company's SOPs;

3. Collect post-marketing AE information, manage the collection, evaluation and processing of products safety information, responsible for ICSR expedited reporting and aggregate safety reporting (PSUR, annual PV report, etc.) to applicable regulatory authorities according to corresponding regulations and company SOPs within timeline;

4. Handle the investigation and management of adverse events, especially death and cluster of adverse events;

5. Participate in the writing of various safety summary reports (such as PSUR and annual summary report) and ensure that they are submitted within the time limit required by regulations.

6. Participate in product life cycle management activities such as product re-registration

7. Participate in PV compliance management within company, ensure the PV compliance of all applicable programs such as marketing and medical programs, etc.

8. Participate in safety signal detection and risk management

9. Keep good communication and collaboration with HAs

10. Participate in describing and demonstrating the PV activities to regulatory authority inspectors during pharmacovigilance or other regulatory authority inspections;

11. Deliver PV training to relevant functions;

12. Participate in management of PV agreements drafting and signing with all kinds of external partners;

13. Manage the preparation, revision and archiving of pharmacovigilance documents, maintain and update all pharmacovigilance records and data.

14. Finish the work assigned by the supervisor.

任职条件:

岗位要求:

Basic Requirements:

1. 医学、药学、公共卫生、流行病学等相关专业,本科以上学历;

2. 4年及以上药物警戒上市后工作经验, 熟悉药物警戒数据库操作者;

3. 熟悉药物警戒相关法规;

4. 良好的英语听说读写能力;

5. 良好的沟通和协调能力。

1. Medical, pharmacology, public health or epidemiology background, etc. with a bachelor’s degree or above ;

2. At least 4 years of post-marketing PV experience, and PV database operating experience;

3. Ideally knowledgeable in Pharmacovigilance relevant regulations;

4. Good English skills on both oral and written;

5. Good communication skills and coordination skills.

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