南平招聘

职位描述：
岗位职责：
requirements, as required for Marketing Authorization holders (MAH).
o Manage and maintain active involvement in day-to-day individual case safety reports (ICSRs) reporting.
o 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.
o Detect and report AEs from Local Scientific Literature.
o Track AE cases and perform case follow-ups as needed.
o Undertake follow-up/investigation of local cases of special interest, e.g., fatal case, cluster ADEs, etc., as appropriate.
o Conduct initial quality review and assessment of local individual cases.
o Perform regular reconciliation activities as required by company procedures and local regulations.
o Ensure an effective system in place for 24-hour coverage.
o Ensure to report Foreign SAE reports of import drugs and SUA reports of global clinical trials to health authorities in compliance with China regulations.
o Ensure to report PSUR to health authorities in compliance with China regulations.
o Ensure implementation and compliance with global, regional and local procedural documents applicable to Pharmacovigilance.
o 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.
o Management and support of PV professionals (if appropriate).
o Check and ensure the proper filing of the drug safety reports according to the company file management and retention policies.
o Ensure local procedure documents maintain and update (if appropriate).
o Provide specific ICSR processing training if appropriate
任职要求：
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, CET-6 举报 分享

       FESCO，中国人力资源行业创始者，中国500强企业。为全球在华万余客户提供全方位人力资源解决方案,包括人事福利外包、招聘测评、外籍人服务、专业外包、专业咨询等。
    北京外企服务集团有限责任公司（FESCO）成立于1979年，是我国人力资源服务行业具有开创意义的***家企业。经过近40年发展，外企集团已经发展成为一个以人力资源外包服务为主，涉及旅游会展、文化传媒、房地产物业等相关领域的企业集团。