ViiV 安全性

Your Responsibilities:
・GPSP関連業務(製造販売後調査等の管理、立案、対応、PMSの進捗管理等)
・安全性定期報告、未知非重篤副作用定期報告対応
・再審査申請準備及び適合性調査対応
・リスクマネジメントプランの策定・改訂及び実施
・市販薬に関連する安全性情報の評価・検討
・市販薬に対する安全対策(医療従事者・患者への情報提供等)の立案
・添付文書作成・改訂業務、情報伝達業務
・市販直後調査関連業務
・契約、自己点検、教育、手順書関連業務

Why You?

Basic qualifications:
スキル
・コミュニケーション能力・対人関係対応能力(社内外のStakeholderとの協調性を持って協業ができる方)
・リーダーシップ能力

経験
・薬機法、GVP/GPSPに関する知識
・安全性又はGPSPの経験3年以上

学位/資格/語学力
・大卒(理系)
・または安全性の経験あれば理系以外も可
・英語力(TOEIC 730点程度)読み、書き、スピーキング
・市販後の安全対策/PMSに興味をもち、熱意をもって安全対策を推進できる方

Preferred qualifications:
NA

Why GSK?:
http://glaxosmithkline.co.jp/viiv/

Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


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