北京招聘

职位描述：
*Responsibilities/Duties
Job summary:
Assist with the overall clinical safety and /or PV & DSS operations associated with products including the entire adverse events process; which may include safety data collected from clinical trial and /or post marketing setting
Manage and process expeditable adverse events to the required standard and submit them to the client and regulatory agencies (if required) within the agreed /stated timelines. Responsible for providing this service to the clients either as a support function to the client project groups or as standalone business.
Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost – effective manner.
Essential Job Duties:
Manage the receipt and processing of all AE report reported either spontaneously from any source or from a clinical trial.
Maintain a strong understanding of Covance’s safety database conventions or client specific dataset conventions, as appropriate.
Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
Begin preparing timely PV reports for products and safety issues, including individual case summary reports of SAE.
Assist in the preparation of listings for annual IND reports, periodic reports and periodic safety update report.
Work with data management or client on reconciliation of safety database
Support / train less experienced safety staff in all aspects of case-handling, adverse event reporting.
Assist with the set-up of and provision of data to, safety committees/DSMBs.
Any other duties as assigned by management
*Education/Qualifications
Associate degree RN + 2 yrs safety experience; OR BS/BA OR MS/MA + 1-2 yrs relevant experience (1 -2 safety experience)
*Experience
Experience:
High degree of accuracy with attention to detail.
Good communication
Knowledge of medical and drug terminology desirable
Familiarity of GCP related to the clinical safety documentation.
Familiarity of ICH guideline
Familiarity of worldwide regulatory requirements and reporting of AE for both marketed and investigational products.
Good written and verbal communication skills.
Ability to work independently with moderate supervision 举报 分享

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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