職位描述
Major Responsibilities:
1. Timely report AE to HQ and local agency within the timeframe.
在規定時限內確保及時向總部和當地藥政管理部門報告不良事件。
1) AE information collection, clarification and review. 不良事件信息收集，澄清和審核。
2) Data entry adverse experience information and released to HQ through internal data base within the timeframe 將不良事件信息及時錄入至特定數據庫并發送至總部。
3) Make sure data quality and data consistency between source data and data entered in the database.確保錄入數據的質量和一致性
2. Be responsible to process and report safety information in clinical study within the time frame to the investigators/ERC and/or local agency.
在一定時限內負責處理安全性報告，并按照ICH/GCP的要求向研究者/倫理委員會和/或當地藥政管理部門及時報告
3. Maintain pharmacovigilance files and safety information on a routine basis.
對相關藥品安全的信息和文件進行維護和管理
4. Provide AE reporting training course to all MSD employee to ensure timely reporting.向所有MSD員工提供不良事件報告要求和程序的培訓
5. Routinely communicate with HQ for AE inquiry and GCP issues.
日常與總部及時解釋和溝通不良事件和相關ICH/GCP的問詢
6. Involve in risk management activities for support scientific evaluation about product safety issue both for local market and clinical research study.
對上市后及臨床研究中的產品安全事宜進行風險管理并提供一定的醫學科學支持.
7. Make appropriate communication with local agency officials for product safety issue. 向當地藥政管理部門通報產品安全性信息并進行適當交流.
Requirements:
?Bachelor degree in medical e.g. physician, clinical research monitor background is preferred.
畢業于臨床醫學專業,有醫生或臨床工作經驗, 或參加過臨床研究,或臨床監察員經驗優先.
?Drug safety working experience is preferred.
藥物安全工作經驗者優先考慮.
?Strong communication skill and team work skill.
較強交流技巧和團隊合作經驗
?Up to date and in-depth knowledge of regulations.
較強的法規意識和領悟力
?be able to work under pressure, sense of responsibility and accountability.
可以出差, 能承受工作壓力, 有較強的工作責任心.
?Be able to have self motivation, do well at working planning and time arrangement.
能自我激勵, 有較強的工作計劃性并合理安排工作時間
