募集要項
- 募集背景
- 戦力強化のため。
- 仕事内容
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多数の革新的な製品を有する外資系バイオ製薬企業で、Patient Safety（PV）【マネジャー/シニアマネジャー】職を募集します！・Serves as or contributes as a member of the J-PS, in developing content and strategy in ICSR.
安全性業務のご経験者でオペレーションを推進頂ける方を求めています。
・Provides support to Director, Associate Director, ICSR, J-PS.
・Ensures successful completion of all assigned activities and projects.
・Well understands all activities and projects performed by global Patient Safety fully aligning with Safety and Business Unit in Japan Affiliate.
・Leads and executes assigned topics and/or reviews: literature ICSRs and evaluate the reportability to PMDA.
・Complies with all regulatory requirements of safety reporting of Regenerative Medicine category in Japan from competent authorities; maintains confidentiality; meets all safety reporting deadlines.
・Support local signal detection activities in collaboration with relevant contact at Safety team member.
・Appropriate input and support for safety descriptions in Japanese Package Insert (J-PI) and associated supporting documentation.
※部下はいません。
- 応募資格
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- 必須
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・Typically requires a degree (BS, BA, MSc or PhD) or professional qualification in a health science field (MD, nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level
・Extensive experience (5+ years) in pharmacovigilance/CT/PMCT and PMS
・Excellent knowledge of pharmacovigilance regulations (Japan, US, EU), ICSR, aggregate safety reports, internal risk management plans, signal detection, clinical and post-market requirements.
・Demonstrates ability to assess complex data sets and understand the safety/medical implications
・Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies
・ビジネスレベルの英語力/読み書き必須
- 歓迎
- ・Regenerative Medicine, Global Pharmaceutical Company, Global workflow experiences by using Argus Safety Database) is preferred.
- フィットする人物像
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・Demonstrates excellent attention to detail, teamwork, and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
・Demonstrates ability to influence others at the same or more junior levels within the organization
・Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point
- 雇用形態
- 正社員
- ポジション・役割
- Patient Safety（Pharmacovigilance）【マネジャー/シニアマネジャー】
- 勤務地
- 東京本社 ※在宅勤務制度あり
- 勤務時間
- 9:00～18:00 フレックス制度あり
- 年収・給与
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1100万円～1330万円（目安） 年俸制
※上記年収にはターゲットボーナスを含む。別途、RSUあり。
※別途、該当者には単身赴任手当等あり。
- 待遇・福利厚生
- 通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、退職金制度、確定拠出年金制度、ベネフィットステーション
- 休日休暇
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完全週休2日制（休日は土日祝日）、年間有給休暇12日～20日（下限日数は、入社直後の付与日数となります）
年間休日日数125日、年末年始休暇、グローバル休暇、有給休暇は初年度は入社日により最大12日付与、傷病休暇
- 選考プロセス
- 【選考プロセス】書類選考⇒面接（3回程度）⇒内定
