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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Specialist or Manager, Pharmacovigilance

Primary Minato, Japan Req ID 2216500 Category Research and Development Division AbbVie


Mission Statement: 


Major Responsibilities:


  • 全てのMedical Activityに対する業界・社内規則の遵守・徹底
  • 日本国内の規制要件およびアッヴィ本社のルールに対するコンプライアンス遵守の維持・向上
  • 薬剤の使用に関する医師他医療従事者およびMR等に対する法令遵守の周知、指導、監督
  • 有害事象発生時の当該事象に関する調査・分析・報告
  • 規制当局への期限内報告(個別症例、各種定期報告)
  • アッヴィ本社(PPS)への期限内有害事象報告
  • 安全性シグナルおよびトレンド変化の検出/監視およびproactiveな適正使用確保措置の実施
  • 医薬品リスク管理計画の策定、策定後のPDCAサイクルの監視および見直し
  • 再審査申請品目の期限内申請
  • その他、過去事例を含む安全性担保のための調査、分析、報告の企画、実施
  • チームメンバーの成長サポート

法規制の遵守:        国内規制要件、AbbVie Policy/SOPの遵守
医薬品リスク管理計画:    J-RMP策定、RMzTおよび関連資材作成
リサーチ、分析、報告:    安全性トレンド変化の検出
SOP/DOP/Local document:    改訂の検討およびレビュー
適合性調査/監査:        適合性調査/監査対応およびCAPAの作成/実行
PV audit:            対応およびCAPAの作成/実行
チームリード:        担当プロジェクトチーム内でのリーダーシップの発揮

Global対応:            PPS (Global PV) からの全般的な問合せ対応(個別事案の問合せ対応に留まらない:Team Managerと協働し、名代として対応することもある)

J-RMP策定に関するPPS (Global PV) からの全般的な問合せ対応

協働:                担当業務関係者との信頼関係構築
部下育成:            後輩社員、派遣社員の指導


Essential Skills & Abilities:


  • ファーマコヴィジランスに関する知識
  • 薬事法、GVP/GPSP省令およびこれに関連する業務の知識
  • 基礎的な医学・薬学的知識
  • リスクマネジメント
  • コンプライアンス


  • 情報収集・分析力
  • 論理的思考力
  • ファシリテーション
  • 英語力
  • 交渉力


  • 患者さん中心/Patient Centric
  • One AbbVieとして/All for one AbbVie
  • 賢明かつ確実な判断/Decide Smart and Sure
  • 迅速性と責任感/Agile and Accountable
  • 明確に、そして勇敢に/Clear and Courageous
  • 可能性の実現/Make Possibilities Real

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Travel: Yes, 5 % of the Time

Job Type: Experienced

Schedule: Full-time

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  • Research and Development, Minato, Wakayama, JapanRemove

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