ファーマコビジランス スペシャリスト/ファーマコビジランス 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2019年 05月 22日

求人情報

ファーマコビジランス

求人管理No.013523

会社概要

ファーマコビジランス スペシャリスト

on recording and reporting of adverse reactions and product quality complaints received from healthcare professionals and consumers under the responsibility of the Drug Safety Officer

募集要項

Pharmacovigilance

・Case entry for adverse events and product quality complaints in Global PV database
・Prepare case submission to local JMAFF authorities for national as well as third country adverse events
・Prepare aggregate report as needed
・Literature searches
・Trending and Signaling
・Participate in internal and external audits/inspections as applicable
・Provide support to DPOC in Development and management of the local pharmacovigilance system, including local pharmacovigilance procedures and relevant documents in compliance with GPV policies and local competent authority regulations
・Provide support to DPOC regarding PV Communications to Global and Regional PV team, all employees and external stakeholders (e.g. vendors, distributors, business partners etc)

Others
・Maintain current knowledge of JMAFF policies and regulations as well as current industry standards and applicable corporate policies related to Pharmacovigilance
・Might be involved in other activities from the Regulatory Affairs team such as maintenance of current licenses or building of dossiers for new products

募集条件

  • Scientific degree (Master or equivalent) in biology, pharmacology or medical sciences, Veterinarian preferred
    One or 2 years of experience in the pharmaceutical industry or in a veterinary practice preferred
    Results orientation and attention to details
    Good communication and scientific writing skills
    Proficient in reading and writing scientific documents in Japanese and in English; able to understand and speak at proficiency level English

勤務開始日

  • 応相談

採用人数

  • 1

勤務地

  • 東京

給与

  • 経験により応相談