【QA】安全管理部・安全対策グループ・マネジャー / Manager, Safety Group, Safety Management Department, QA 【業務内容】 複数名の安全対策グループメンバーを管理します。人材の採用・育成・担当業務の割り振り・業務管理・目標管理・勤怠管理に責任を持ちます。 安全管理責任者の指示のもと、製品出荷後の苦情・安全管理情報(品質、有効性及び安全性に関する事項その他医療機器の適正な使用のために必要な情報)を収集、検討及びその結果に基づく必要な措置(安全確保措置)を担当者に行わせ、また自らも実施します。 安全確保措置の実施にあたっては、責任と解決策を明確にするため、社内関係者(営業部、マーケティング部、オペレーション部、薬事本部、臨床開発部及び法務本部等)、業界団体及び行政関係者との調整を担当者に指示し、または自らも調整を行います。 苦情・安全管理情報の収集、検討及び安全確保措置の実施に必要なプロセス、手順及び管理方法の改善を図り、健全な状態に維持します。プロセス、⼿順及び管理方法を維持するため、苦情・安全管理情報の収集、検討結果をレビューし、必要に応じて担当者へのフィードバックをするとともに、当社製品の市場におけるパフォーマンスをモニターし、安全管理責任者へレポートし、問題解決のための是正措置を実施します。 苦情・安全管理情報を海外製造元と共有し、必要に応じて対策を協議します。 使用成績調査対象製品について、市販後安全性情報および安全確保措置の実施結果について担当者へ主管部門連携を指示し、使用成績調査対応の支援を行います。 各種プロジェクトに対して、安全対策グループとしてのリソース提供を検討、実行し、製造販売業者としてのコンプライアンスの維持を確実にします。 【必須経験】 1. 5年以上の医療機器製造販売業者における製造販売後安全管理(GVP)業務経験(クラスⅣデバイスであれば尚可) 2. 2年以上のマネージメント経験 3. 関連諸官公庁(MHLW、PMDA、TMG)担当者との対応経験 4. 都道府県庁、PMDA又は認証機関による査察対応 5. マトリックス組織でのプロジェクト対応 6. 英語力(ビジネスレベル、電話会議可能) 【勤務地】 ・本社(東京都中野区) Boston Scientific
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Tokyo Boston Scientific Full time複数名の安全対策グループメンバーを管理します。人材の採用・育成・担当業務の割り振り・業務管理・目標管理・勤怠管理に責任を持ちます。 · ...
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Tokyo Boston Scientific安全管理部・安全対策グループ・マネジャー / Manager, Safety Group, Safety Management Department · ...
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Tokyo Boston Scientific複数名の安全対策グループメンバーを管理し、製品出荷後の苦情・安全管理情報を収集検討及びその結果に基づく必要な措置を行います。... · ...
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Chūō Johnson & Johnson Innovative Medicine Full timeGVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan. · ...
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東京都 中央区, Johnson & JohnsonA Safety Management Specialist at Johnson & Johnson will work in Tokyo Office closely with Safety/GVP manager to handle adverse events reports to PMDA Japan. · ...
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Chuo-ku, Tokyo Johnson & Johnson MedTechThe Safety Management Specialist-GVP Heart Recovery at Johnson & Johnson believes health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. · Creating and submitting adverse event reports to ...
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Chuo-ku, Tokyo myGwork - LGBTQ+ Business CommunityThis job is with Johnson & Johnson. GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan. · Minimum 2 years of GVP and/or post-market engineering experience in the medical industries. · Good knowledge ...
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Sagamihara myGwork - LGBTQ+ Business CommunityThis job is with Johnson & Johnson. At Johnson & Johnson, we believe health is everything. We are responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan. ...
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Sagamihara Johnson & Johnson MedTechAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured. · ...
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東京都, 日本, Intuitive+ · The Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint handling filings. · +Preparation and implementation of GVP in compliance with Japanese PAL. · Careful follow up of information sent to users and regulatory agencies. · ...
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Tokyo Intuitive ¥2,500,000 - ¥5,000,000 per yearThe Safety Control Specialist is responsible for timely post-marketing filings (GVP) and complaint handling filings. · Preparation and implementation of GVP in compliance with Japanese PAL. · Collection and first reviewer of local and overseas post-marketing safety informatio ...
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Tokyo, Tokyo GE HealthCareThe Pharmacovigilance (PV) Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act (PMD Act) to ensure the safe and compliant commercialization of pharmaceutical products in Japan. · Serve as the Anseki (Safety Management Su ...
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医療機器 安全管理業務
22時間前
東京都, 日本, Intuitive ¥5,000,000 - ¥10,000,000 per yearThe Senior Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint handling filings. Maintain post marketing and complaint handling documentation with necessary filings and communications to appropriate parties. · Roles and Responsibil ...
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医療機器 安全管理業務
2ヶ月前
Tokyo Intuitive ¥4,500,000 - ¥6,300,000 per yearThe Senior Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint handling filings. Maintain post marketing and complaint handling documentation with necessary filings and communications to appropriate parties. · Careful documentation ...
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Tokyo, Japan Sitero LLC FreelanceThe Local PV Officer works collaboratively with Global PV staff and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws. · ...
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Navigation QA
2週間前
Tokyo TEKsystemsJoin a fast-growing startup backed by a major automotive leader driving innovation in EV and smart mobility solutions. · ...
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Tokyo Brown-Forman ¥60,000 - ¥120,000 per yearThe Quality Assurance specialist will be responsible for the food safety and quality assurance, warehouse site assessment, and analysis, reporting and process improvement of the third party logistics (3PL) partner for Brown Forman owned products. · This role is responsible for en ...
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QA engineer
1ヶ月前
Tokyo, Tokyo G TalentThe company provides a wide range of support solutions to assist customers. The QA is involved in quality assurance work to ensure the safety and security of products as the first user who actually uses the product before it is delivered to the customer. · Full social insurance · ...
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Tokyo, Tokyo BioMarin Pharmaceutical Inc. ¥8,000,000 - ¥12,000,000 per yearThis position reports to the Associate Director of In Market Quality and will maintain responsibility, oversight, and management of quality-related activities for drug product releases to Japan and APAC region as required. · The Quality Assurance Manager is responsible for the su ...
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Project Manager
3週間前
Tokyo LVI AssociatesWe are seeking an experienced Project Manager to lead construction and execution of utility-scale Battery Energy Storage System (BESS) projects in Japan. · ...
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Tokyo, Tokyo TOA Construction ¥60,000 - ¥120,000 per yearWe are the main contractor for a large-scale data center project in Japan. This is a long-term, flagship project where you can be involved from early design coordination through construction and commissioning. ...