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【ディレクター】職を募集します！・Serves as or contributes to a lead member of the J-PS, in developing content and strategy.
安全性業務の実務を熟知、俯瞰し、戦略的・実践的なチームビルドができる方を求めております。
・Provides support to J-PS Senior Director directly
・Oversees and ensures successful completion of all assigned activities and projects.
・Well understands all activities and projects performed in multiple therapeutic areas.
・Leads assigned topics and/or reviews: literature for ICSRs and other report types including Foreign Safety Measure report criteria and Japan Research Report criteria.
・Complies with all regulatory requirements of Pharmacovigilance regulations globally from competent authorities; maintains confidentiality; meets all safety reporting deadlines.
・Signal detection and authorship of signal work-up documents in collaboration with relevant contact at global Therapeutic Areas members.
・Appropriate input and support for safety descriptions in Japanese Package Insert (J-PI) and associated supporting documentation.
- 応募資格
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- 必須
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・Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., 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, preferred) in pharmacovigilance/PMS (Oncology therapeutic area) is required.
※安全性業務の実務を熟知、俯瞰し、戦略的・実践的なチームビルドができる方
・ビジネスレベルの英語力
・Excellent knowledge of pharmacovigilance regulations aggregate safety reports, internal risk management plans, signal detection, clinical trials, and clinical development.
・Demonstrates ability to assess complex data sets and understand the safety/medical implications.
- 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 good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies.
・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（ファーマコビジランス）【アソシエイトディレクター～ディレクター】
- 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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1300万円～1500万円（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
- キャリアパス・評価制度
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→職務内容続き
・Authorship of aggregate safety reports (e.g., J-PSR, Non-serious unlisted line-listing reports, J-DSURs).
・Authorship of responses to regulatory agency safety enquiries (RtQ).
・Contributes to safety analyses in Regulatory submissions (e.g., Business License Applications and Renewals, Marketing Authorization Application, New Drug Application in collaboration with relevant Global PS functions.
