Key Accountabilities
• Perform medical review for ICSRs.
• Perform medical review for medical coding.
• Participate in development of draft SAE narratives.
• Participate in development of Development Safety Update Report (DSUR), Risk Management Plan (RMP), drug safety report and other documents.
• Participate in review of statistical analysis plan (SAP), DMC charter and other documents as required by the study.
• Request additional tables or analyses where appropriate.
• Review individual data with serious adverse events and potentially clinically important laboratory test or vital sign abnormalities.
• Participate in all reviews and procedures required for safety database lock.
• Review outstanding medical or GCP issues report and address issues across the study.
• May determine need for and request follow-up using appropriate communication methods (eg. fax, email, telephone or site visit).
• Participate in team discussion for both processing and product knowledge.
• Be available to answer questions specific to the protocol during the study ongoing.
• Other tasks arranged according to departmental development requirements.


Skills
• Good computer skills including but not limited to the knowledge of Clinical Trial/PV Systems/Data Management Systems, MS-Office products such as Excel, Word
• Demonstrate a sound awareness of all relevant regulations, including GCP, GVP, etc.
• Ability to successfully work in a (‘virtual’) team environment
• Client focused approach to work
• Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
• Solid interpersonal, verbal and written communication skills
• Sense of urgency in completing assigned tasks
• Meticulous attention to detail
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work

Education
• Master or above degree with medical qualification or relevant medical experience

Language Skills
• Competent in written and oral English.

其他信息
语言要求：英语
行业要求：全部行业