AbbVie

Manager, PARM

AbbVie  •  Tokyo, JP (Onsite)  •  17 days ago
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Job Description

企業概要

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

求人内容

Missions:

The appropriateness of information provision activities in AbbVie is ensured by assisting in the development of an internal code system/examination review system as a sales information provision activity supervision department in accordance with relevant laws and regulations (pharmaceutical machinery law, proper advertising standards, sales information provision activity guidelines, etc.), industry standards (pharmaceutical cooperation codes, material preparation procedures, fair competition rules, etc.) and AbbVie internal ethics/regulations relating to promotion activities, and communicating with internal and external stakeholders.

Main job description:

  1. Operations related to formulation/revision of in-house codes
  2. Services related to education/training
  3. Operations related to monitoring
  4. Deviation-related operations
  5. Operations related to challenges/escalations from implementation departments, etc.
  6. Examination of various promotional materials
  7. Review work for slides of lectures, etc.
  8. Pre-examination/review consultation/inquiry handling services
  9. Secretariat operations such as the Examination/Supervisory Committee/Scientific Advisory Board/Mutsuki Association

Role details:

  1. Formulation and revision of AbbVie's in-house code in accordance with the Pharmaceutical Cooperative Code
  2. Planning and implementation of education/training on various codes/rules, etc. related to promotion activities
  3. Risk analysis and examination of countermeasures through continuous activity monitoring
  4. Deflation related support (including VVR)
  5. Response to challenges/escalations from implementation departments, etc.
  6. Establishing review standards for lecture slide reviews and ensuring consistency of review comments
  7. Appropriate review of examination standards and processes, and disseminate and thoroughly implement them to the commercial department
  8. Pre-examination consultation and response to inquiries
  9. Functional operation support for review and supervisory committees and scientific advisory boards
  10. Collection of information on other companies through Mutsuki Association

Main Job description:

  1. 自社コードの策定/改定に関する業務
  2. 教育/トレーニングに関する業務
  3. モニタリングに関する業務
  4. デビエーションに関する業務
  5. 実施部門等からのチャレンジ/エスカレーションに関する業務

Role details:

  1. 製薬協コードに準æ‹ ã—ãŸã‚¢ãƒƒãƒ´ã‚£è‡ªç¤¾ã‚³ãƒ¼ãƒ‰ã®ç­–å®šãªã‚‰ã³ã«æ”¹å®š
  2. プロモーション活動に関わる各種コード/ルール等に関する教育/トレーニングの企画・実施
  3. 継続的な活動モニタリングを通じたリスク分析と対応策の検討
  4. デビエーションに関する対応(AAR含む)
  5. 実施部門等からのチャレンジ/エスカレーションへの対応
  6. æ¥­ç•Œæƒ…å ±ã€ä»–ç¤¾æƒ…å ±ã®åŽé›†
  7. AMTへのレポート/é–¢ä¿‚éƒ¨é–€ãƒ»å®Ÿæ–½éƒ¨é–€ã¨ã®æƒ…å ±å…±æœ‰æ¥­å‹™
  8. æ¥­ç•Œã‚¹ã‚¿ãƒ³ãƒ€ãƒ¼ãƒ‰ã‚’ç†è§£ã—ã€ç¾çŠ¶èª²é¡Œã‚’æ§‹é€ çš„ã«æ‰ãˆã€é–¢ä¿‚éƒ¨é–€ã«å¯¾ã—è«–ç†çš„ã‹ã¤ç´å¾—æ€§ã®é«˜ã„èª¬æ˜ŽãŒã§ãã‚‹äººæã‚’è‚²æˆã™ã‚‹

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Required competencies and experience:

  1. Practical experience in supervisory department work or material review work in the pharmaceutical industry (3 years or more)
  2. In-depth knowledge and understanding of relevant laws, industry norms, internal rules, etc.
  3. University graduate or above (pharmacy, medical recommendation)
  4. People with experience on the Pharmaceutical Cooperative Committee, etc. (preferred)

Education and training:

  1. Bachelor’s degree or above (recommended for pharmacy, medicine, law, etc.

Required competencies and experience:

  1. 製薬業界における監督部門業務(3年以上)の実務経験
  2. 関連法規、業界規範、社内ルール等への深い知識と理解
  3. ハイレベルなリスク管理能力と正しい分析や改善提案(CAPA)能力
  4. 社内関係者への説明力とコミュニケーション力
  5. 社外関係者との人脈、関係性構築力
  6. 製薬協委員の経験者(尚可)

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AbbVie

About AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

Learn more about us at www.abbvie.com and review our community guidelines at https://www.abbvie.com/social-media-community-guidelines.html.

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
North Chicago, Illinois
Year Founded
Unknown
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