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某合资药企招聘药物安全运营专员

更新时间:2016-11-11
工作地点:北京华贸
薪资待遇:面议 
工作职责:

Maintain overall responsibility for the coordination of safety reporting requirements, as required for Marketing Authorization holders (MAH).

  • Manage and maintain active involvement in day-to-day individual case safety reports (ICSRs) reporting.
  • Key responsibilities include collection, review and reporting of individual case safety reports (ICSRs) and ICSRs combined with product quality complaints (ICSRs+PQCs), obtained through the following sources: spontaneous, solicited, clinical trials, related research activities, local Competent Authorities and all other potential sources, to local Competent Authorities and Global Medical Safety/Office of Consumer Medical Safety, according to local regulations and company procedure documents.
  • Detect and report AEs from Local Scientific Literature.
  • Track AE cases and perform case follow-ups as needed.
  • Undertake follow-up/investigation of local cases of special interest, e.g., fatal case, cluster ADEs, etc., as appropriate.
  • Conduct initial quality review and assessment of local individual cases.
  • Perform regular reconciliation activities as required by company procedures and local regulations.
  • Ensure an effective system in place for 24-hour coverage.
  • Ensure to report Foreign SAE reports of import drugs and SUA reports of global clinical trials to health authorities in compliance with China regulations.
  • Ensure to report PSUR to health authorities in compliance with China regulations.
  • Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance.
  • Accountable internally for ensuring that the Local Operating Company meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports. 

• Other responsibilities.

  • Management and support of PV professionals (if appropriate).
  • Check and ensure the proper filing of the drug safety reports according to the company file management and retention policies.
  • Ensure local procedure documents maintain and update (if appropriate).
  • Provide specific ICSR processing training if appropriate. 

任职资格:

A. Education/training background:

• Bachelor or higher education of medicine/pharmacology.

B. Knowledge/skills:

• Medical and pharmaceutical knowledge;

• Good at English in listening, speaking, reading and writing;

• Good computer application skills.

C. Work experiences:

• two years’ experience of drug safety in international pharmaceutical companies

D. Competencies:

• Good capability of communication, cooperation and teamwork.

• Ability of continuous learning to improve comprehensive qualities.

E. Others:

• Fluent spoken and written English,(Above TOEIC 800 or IELTS 6.5)

用工形式:有意者请向 wang.jun.ye@fesco.com.cn发送简历,标题请注明应聘职位
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