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| 部署・役職名 | 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】 |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
・Serves as or contributes to a lead member of the J－PS, in developing content and strategy. ・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. ・Authorship of aggregate safety reports （e.g., J－PSR, Non－serious unlisted line－listing reports （NSUL）, 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 （MAAs）, New Drug Application （NDAs） in collaboration with relevant Global PS functions. ・Reviews and inputs appropriately clinical trial protocols, investigator brochures （IB）, final study reports （FSR）, informed consent forms （ICF）, and other study related documents on team review or RDMS final review. ・Oversights CRO activities for the Risk Management and or Operations regarding relevant safety information handling and resolve any issues ensuring to comply with safety requirements. ・Sets－up and oversight of Early Post－marketing Phase Vigilance （EPPV） activities. And authorship of protocol, interim/final reports. ・Collaborates with PMS manager/study lead for timely execution of PMS activities as they relate to single case management to comply with local GPSP requirements. ・May act as deputy Safety Manager in Japan to comply with J－GVP requirements. ・Participates on and may lead various cross－functional teams, involving interaction with our staff within and outside of J－PS department, to convey and acquire safety information internally and externally. ・Contributes to the Risk Management and or Operations teams for directing highly complex communications and ensuring that all customers are fully informed and knowledgeable of project activities and their status. ・May recruits, hires, mentor and manage direct reports within J－PS with responsibility for employee performance evaluations; mentors and manages direct reports; mentor junior staff to ensure competence in pharmacovigilance of multiple therapeutic areas. ・Contributes to audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to multiple therapeutic areas. ・Participates in both internal and external educational initiatives. ・May participate in budget planning and management in the J－PS teams. ・Well understands and follows global and long－term goals for multiple therapeutic areas, in collaboration with department heads, considering and providing support for the strategic goals of the organization. ・Demonstrates independent thought and initiative in the preparation and completion of projects. ・Recognized as an expert on pharmacovigilance regulations, aggregate safety reports, internal risk management plans, signal detection, clinical trials, and clinical development within J－PS and by external departments. ・Presents results and findings and discusses processes in formal settings with consideration of the impact on processes within and outside of J－PS, and mentors more junior level employees in these activities. 【勤務地】 東京本社 ※フレックス制度、在宅勤務制度あり |
| 労働条件 |
※労働条件の詳細は、ご⾯談時にご説明いたします（年収⽬安︓1300万円〜1800万円⽬安） 年俸制 ※年収にはターゲットボーナスを含む。※別途、RSUの支給有り。 【雇用形態】正社員 【受動喫煙対策】敷地内全⾯禁煙 |
| 応募資格 |
【必須（MUST）】 ・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.・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. ・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. ・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（読み書き必須、スピーキングはそこまで高いレベルでなくても可） 【求める人物像】 ・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. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/01/11 |
| 求人番号 | 3107675 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です