• 招聘类型：社招
• 工作性质：全职
• 所属区域：北京 - CBD
• 直属部门：PV

职位描述

Assist to manage potential safety issues, safety and benefit-risk evaluations for assigned products, assist in creation of safety signal detection and assessment report.Assist to creation and/or review of key documents in the context of safety and benefit risk for assigned products (RMP, IB, NDA submissions, ad hoc expert reports, DSUR, PBRER and other required aggregate safety analyses).Review adverse event reports from clinical trials and issue medical queries on a regular basis, help oversight of vendor activities related to safety adverse event medical review as needed.Supporting responses to queries from Health Authorities and Ethics committees. Working with Safety Operations to:Ensure safety data required for ad hoc regulatory queries complies with the request.Ensure outputs of safety data from both safety and clinical trial databases meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities.

任职条件

Master’s level degree or above in life sciences, pharmacy, nursing or medical. MD degree with subspecialty training preferred.5 years or more PV work experience in the Pharmaceutical or CRO industry.Working knowledge of Microsoft Office and ARGUS. Familiarity with data mining tools and exploratory analyses tools such as Spotfire. Excellent communication and interpersonal skills .Fluent in English (writing and speaking)

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要