张女士
一周前在线
已认证
- 职位介绍
- 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
公司简介
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处。目前拥有1000+的国际化专业团队。
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