职位描述
Major Responsibilities:
1. Timely report AE to HQ and local agency within the timeframe.
在规定时限内确保及时向总部和当地药政管理部门报告不良事件。
1) AE information collection, clarification and review. 不良事件信息收集，澄清和审核。
2) Data entry adverse experience information and released to HQ through internal data base within the timeframe 将不良事件信息及时录入至特定数据库并发送至总部。
3) Make sure data quality and data consistency between source data and data entered in the database.确保录入数据的质量和一致性
2. Be responsible to process and report safety information in clinical study within the time frame to the investigators/ERC and/or local agency.
在一定时限内负责处理安全性报告，并按照ICH/GCP的要求向研究者/伦理委员会和/或当地药政管理部门及时报告
3. Maintain pharmacovigilance files and safety information on a routine basis.
对相关药品安全的信息和文件进行维护和管理
4. Provide AE reporting training course to all MSD employee to ensure timely reporting.向所有MSD员工提供不良事件报告要求和程序的培训
5. Routinely communicate with HQ for AE inquiry and GCP issues.
日常与总部及时解释和沟通不良事件和相关ICH/GCP的问询
6. Involve in risk management activities for support scientific evaluation about product safety issue both for local market and clinical research study.
对上市后及临床研究中的产品安全事宜进行风险管理并提供一定的医学科学支持.
7. Make appropriate communication with local agency officials for product safety issue. 向当地药政管理部门通报产品安全性信息并进行适当交流.
Requirements:
?Bachelor degree in medical e.g. physician, clinical research monitor background is preferred.
毕业于临床医学专业,有医生或临床工作经验, 或参加过临床研究,或临床监察员经验优先.
?Drug safety working experience is preferred.
药物安全工作经验者优先考虑.
?Strong communication skill and team work skill.
较强交流技巧和团队合作经验
?Up to date and in-depth knowledge of regulations.
较强的法规意识和领悟力
?be able to work under pressure, sense of responsibility and accountability.
可以出差, 能承受工作压力, 有较强的工作责任心.
?Be able to have self motivation, do well at working planning and time arrangement.
能自我激励, 有较强的工作计划性并合理安排工作时间
