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Country Safety Head

年収：1500万～ 2000万

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部署・役職名	Country Safety Head
職種	マーケティング・企画
業種	医薬品メーカー
勤務地	東京都
仕事内容	Main responsibilities: • The face of the Safety organization in the country • Accountable for all PV related activities in the country & ensures that the local PV teams are properly trained to manage these activities • Ensures inspection readiness of the PV system in the country, serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed) • Operate as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head (this role can be delegated as needed). • Builds & maintains all necessary relations/collaboration with the key PSPV stakeholders as well as other CSHs, and with the in-country partner functions (including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Lead). • Accountable for local PV outsourced activities and PV compliance of local partnerships
応募資格	【必須（MUST）】 Experience: • Strong experience with PV Systems & Regulatory Agency Interactions Soft skills: • Strong leadership, able to create networks and to collaborate in an international crossfunctional environment • Self–motivated, ruthlessly prioritize to deliver most value • Solution oriented & strategic thinking while keeping patients and customers top of mind • Good communicator with attention to detail while seeing the big picture Technical skills: • Strong knowledge of pharmacovigilance systems & regulations • Good understanding of how to manage safety data from multiple sources • Able to evaluate & manage safety signals and define risk management activities Education: • Advanced health care discipline degree (MD, PharmD, PhD, Master of Science, etc) or equivalent qualification Languages: • Business English language proficiency 【歓迎（WANT）】 • The CSH must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country(ies) • Strong knowledge and expertise in national (pharmacovigilance including medical products, vaccines, and medical devices, when relevant) regulations and international regulations as well as industry standards Key functional competencies • Medical Safety Landscape Demonstrates understanding and compliance with the regulatory, therapeutic, and clinical environment in order to effectively define and re-evaluate the safety profile throughout the product’s life cycle. Sufficient ability to interpret clinical data including safety data. • Signal Detection: Safety Surveillance & Data Gathering Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect and validate potential signals. Continuous evaluating and adopting the most suitable tools to optimize the collection of safety information and detection of signals. • Signal Assessment & Risk Identification Ability to evaluate safety signals to determine causality and impact of signal or risk, risk factors and confounding factors. • Risk Management Ability to define risk management activities and apply appropriate methods to characterize, avoid or reduce risks to patients and clinical trial subjects when applicable. Patient Safety & Pharmacovigilance (PSPV) Inclusive & Detailed Job Description Form
アピールポイント	自社サービス・製品あり外資系企業女性管理職実績あり従業員数1000人以上シェアトップクラス年間休日120日以上産休・育休取得実績あり教育・研修制度充実マネジメント業務なし完全土日休みフレックスタイム
受動喫煙対策	その他「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日	2025/04/21
求人番号	4565777

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