Drug Safety Specialist 北京

月薪： 1-1.5万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招2人
  • 03-02 发布
  • 专业培训
  • 员工旅游
  • 定期体检
  • 补充医疗保险
  • 弹性工作
  • 五险一金
  • 通讯补贴

职位描述

Essential Functions: 1. Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance. 2. Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project specific safety plans. a) Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability. b) Enters data into safety/adjudication database. c) Performs Quality Control (QC) of entered data/endpoint dossiers. d) Codes events, medical history, concomitant medications and tests. e) Compiles complete narrative summaries. f) Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved. g) Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. h) Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. 3. Assists safety project lead/endpoint manager in the preparation of a safety management plan. 4. Distributes all required periodic reports for both clinical and post-marketing projects. 5. Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements. 6. Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients. 7. Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process. 8. Maintains knowledge of ongoing projects and disease-related terminology. Requirements: BA/BS in Life Science or Registered Nurse/Pharmacist. Nominal clinical/clinical research experience or equivalent combination of education and experience. Safety and Pharmacovigilance experience. Clinical Research Organization (CRO) experience with therapeutic specialties preferred. Knowledge of safety database preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet. Some understanding and usage of medical terminology. Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting. Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy and meet deadlines in a highly dynamic environment. Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment. 职能类别： 其他

联系方式

国贸

公司信息

InVentiv Health通过分布在全球70多个国家的14000名员工，为医药、医疗器械和生物工程客户提供临床研发、销售及商务咨询服务，inVentiv Health的目标是通过自身的专业服务将客户的商业理念真正地转化为现实，帮助客户提升业绩，现在inVentiv Health服务于约550家客户的850个品牌。 2011年12月，inVentiv Health在中国设立盈帆达医药咨询（上海）有限公司，正式在中国区域为医药行业客户提供服务。 inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.

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