职位描述:

能够独立处理以下药物警戒事务：

1. 协助药物警戒负责人建立并改进药物警戒体系以确保其有效性和遵守所有适用的法规和公司政策及标准操作规程；

2. 参与相关临床资料的审核，例如：研究方案，知情同意书，病例报告表等，以满足药物警戒合规及安全管理的要求；

3. 参与国内外临床项目的PV项目管理。

4. 参与研究者手册（IB）和标签的制定和更新，尽可能充分说明安全性风险；

5. 根据医学判断和经验，对个例病例进行医学评价、定期安全性报告（DSUR/PSUR）、以及安全信号检测、评估和管理提供充分的医学支持；

6. 为提交新药申请（NDA）准备风险管理计划（RMP），包括上市后药物警戒措施，以监测新产品批准后的安全性；

7. 新药申请（NDA）提交时，递交安全部分，包括安全方面的决策和监管资料；

8. 参与管理与各种外部合作伙伴起草和签署药物警戒协议；

9. 确保所有内部和外部客户之间的良好沟通和协作，同时确保维持好所有药物警戒标准；

10. 在药物警戒工作中，与监管部门保持良好的沟通；

Key Objectives/Deliverables:

Qualified individual, with minimum supervision, be able to:

1. Supports the PV head on the establishment and improvement of a PV system to ensure its efficiency and compliance following all applicable regulations and company policies and SOPs.

2. Participates in review of relevant clinical documents such as study protocol, ICF, CRF, etc. to ensure the PV compliance and safety management requirements.

3. Participates in PV project management of domestic and global trials.

4. Participate in the development and update of Investigator’s Brochure (IB) and labelling, making sure safety risks are adequately addressed in the documents.

5. Provide enough medical expertise for medical review of individual cases, periodic safety reporting (DSUR/PSUR), and safety signal detection, evaluation and management based on medical judgment and clinical experience.

6. Prepare Risk Management Plan (RMP) for NDA submission to include post-marketing PV measures for monitoring the post-approval safety of the new product.

7. Deliver the safety sections in NDA submissions including safety aspects of decision-making, and regulatory documents.

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

9. Ensures good communication and collaboration between all internal and external customers, while at the same time ensures that all Pharmacovigilance standards are maintained.

10. Keep good communication with Health Authorities during PV operation;

任职条件:

1. 至少5年制药行业药物警戒经验或其它相关行业经验，有临床研究药物警戒医师经验者优先；

2. 熟悉药物警戒相关法规；

3. 熟悉产品开发流程；

4. 熟悉药物警戒数据库系统操作，例如：Argus系统，Arisg系统等；

5. 具有跨职能团队工作经验；

6. 硕士学位及以上；

7. 医学、药学、公共卫生或流行病学专业，医学优先；

8. 有临床培训和实践经验者优先；

9. 良好的英语挺熟读写能力

Basic Requirements:

1. At least 5 years of PV experience in the pharmaceutical industry or relevant equivalent experience, clinical development PV physician experience is preferred.

2. Ideally knowledgeable in Pharmacovigilance relevant regulations.

3. Good knowledge of product development process.

4. Familiar with PV database practice, such as Argus, ARISg, etc.

5. Experience of cross-functional teamwork.

6. Master degree or above.

7. Major in medical, pharmacy, public health, or epidemiology，medical is preferred.

8. Prefer with clinical training and practice experience.

9. Good English skills in both oral and written.