北京招聘

？Process adverse event reports received from sites/reporters.

？Perform QC review of completed individual and periodic safety reports.

？Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.

？Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter.

？Engage with the Site Monitors to ensure follow up information is obtained from site effectively.

？Foster constructive and professional working relationships with all project team members, internal and external.

？File documents according to project specific requirements (electronically or in hard copy as applicable).

？Ensure case files are compliant with SOPs.

？Distribute safety data reports to other Sr. Safety Associate peer and Medical Monitor for review.

？Distribute safety data reports to clients and other relevant parties.

？Responsible for ensuring project deliverables are completed on time and with high quality.

？Ensure compliance with company policies, procedures, and standards.

？Participate in the development of safety SOPs and Operating Guides.

？Participate in project meetings.

？Participate in audits as required/appropriate.

？Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects.

？Lead in the development of case management related SOPs and Operating Guides.

？Assist with preparation/compilation, and review of safety aggregate reports.

？May be responsible for distributing and monitoring team workload.

？Provide support for Safety Lead with miscellaneous project tasks related to case management.

？Mentor and train other associates on processes regarding case processing.

？Perform literature review as appropriate for Post-Marketing cases.

？Communicate with other departments and clients as directed by project lead to ensure compliance with safety and PV SOP’s.

？Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.

？May have direct reports.

？Any other duties as assigned by manger.

Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.

多年来一直专注于于为世界500强，跨国公司，国内上市公司提供管理咨询，人力资源咨询和中高端招聘服务，为中高级职业经理人提供更好的职业发展机会。
在中国服务力量遍布在北京、上海、广州、深圳、成都、南京、宁波、苏州等多个城市, 超过100名专业咨询顾问。