Drug Safety Managerの転職・求人情報 30815873

募集要項

仕事内容: 安全性業務全般
Basic purpose of the job
－ Manage case processing activities for investigational and marketed products including case submission to GPV and PMDA according to the company's internal procedure and local regulation.
－ Conduct safety risk management activities for assigned compounds by establishing and maintaining J－Risk Management Plan which fulfils compliance with the company’s internal procedures and local regulation
－ Manage PV business operational tasks including SOP ＆ Training and Quality Check of deliverables. Ensure quality of service level provided by vendor and maintain PV system

応募資格

必須: － Knowledge of local and international PV regulation
－ Knowledge of local and international NIS study
－ 3＋years’ experience in pharmacovigilance
－ Bachelor’s Degree　
－ Business level proficiency in English
－ Evaluation of safety information including individual case safety reports
－ Proactive and assertive attitude, a team player

フィットする人物像: こんな方なら向いている
ー　持続可能な成長を優先し、収益優先よりも研究開発への投資を重要視するコアバリューを持っている環境を求める方
ー　大手外資製薬でも縦割りの分業ではなく、幅広い業務内容を担当したい方
ー　柔軟的な働き方をしながら業務に携わりたい方

事業内容・会社の特長: Global market leader and one of the world's largest pharmaceutical companies with a R＆D oriented culture. The company's key areas of interest are respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system.