募集要項

仕事内容: ルンドベック・ジャパン株式会社での募集です。
安全性情報（臨床開発・製販後GVP）のご経験のある方は歓迎です。
Purpose of the job:
This role is a critical addition to Lundbeck Japan's Drug Development organization reporting to the Head of Patient Safety Japan. The individual will serve as a senior pharmacovigilance professional responsible for supporting the safety oversight of Lundbeck's expanding product portfolio in Japan including both marketed products and pipeline assets approaching regulatory milestones. The role is positioned at a level where the successful candidate would be expected to develop toward readiness for broader safety responsible leadership including eligibility for the Deputy Anseki designation under the PMD Act and J GVP regulations. This requires someone who combines deep pharmacovigilance expertise with the independence judgment and collaborative approach needed to contribute meaningfully in a lean and growing organization.

Responsibilities:
・ Serve as the primary backup to the Head of Patient Safety Japan including acting as Deputy Anseki when r…

応募資格

必須: Education / Certifications:
・ Bachelor's degree in pharmacy life sciences nursing public health or related field required. Advanced degree （MSc PhD PharmD） preferred.
・ Good Clinical Practice （GCP） and Good Vigilance Practice （GVP） training.

Experiences
・ Minimum 10 years of pharmacovigilance experience in the pharmaceutical or biotechnology industry with substantial exposure to Japan specific PV regulations （GCP GVP）.
・ Demonstrated experience interacting with the PMDA and supporting regulatory inspections.
・ Proven track record in managing outsourced pharmacovigilance operations including CRO/vendor oversight case processing quality management and PVA governance.
・ Experience contributing to or leading the preparation of J RMPs aggregate report in…

フィットする人物像: JAC Recruitmentでは、担当コンサルタントが直接企業へ訪問。だからお伝えできることがあります。
面談の際に、採用担当者からお聞きした情報やコンサルタント自身が感じた選考のポイントを皆さまへお届けします。

待遇・福利厚生: 【通勤手当】全額支給交通費は半年分の定期代を1月と7月に支給しています。（期中入社の場合は、日割り計算）
【社会保険】健康保険
厚生年金
雇用保険
労災保険

休日休暇: 【有給休暇】年間有給休暇：入社月により変動
【休日】完全週休二日制
土
日
祝日
年末年始（12/29 1/3）、傷病休暇
※有給休暇：試用期間中は5日間まで入社7ヶ月目には最低10日以上

会社概要