【特集】安全性情報に関わるマネージメント業務の求人一覧

製薬メーカーでの安全性情報管理業務

仕事内容

GVP 省令に基づく医療用医薬品を主とした安全性情報管理業務（一部、OTC等含む）
・国内外の安全性情報の収集・評価・措置検討
・海外提携先への安全性情報の提供
・安全性情報に基づく措置実施（情報提供、当局報告）
・RMPならびに添付文書注意事項等情報の作成・改訂
・当局ならびに提携先からの査察時対応

応募条件

【必須事項】
・医薬品GVP 下での３年以上の安全性情報管理業務経験
【歓迎経験】
・CIOMSや英語文献の副作用評価経験
・副作用管理データベースの使用経験
・GPSP下での製造販売後調査等管理業務経験
・薬剤師免許
・メンバーの指導・育成、マネジメント経験
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

550万円～800万円　

日本の安全機能に代わってグローバルな意思決定に影響を与える

仕事内容

. Provide technical leadership in safety work internally and externally for environmental shaping

1.Influence global decision on behalf of safety function in Japan
Be most updated with regulatory/safety environment and industrial/global trend on safety through various channels, and building relationship with external customers/stakeholders
Foresee environment changes based on expertise, experiences and knowledge obtained internally and externally in the safety area, and develop strategy and execution plan for environmental shaping
Influence on its changes which value for patients and customers in a proactive way partnering with other functions/stakeholders
Input Japan’s opinions about related matters and influence discussions and decisions made by industrial members and/or regulatory authorities.
Build a strong working relationship with the Global Process Owners, individual Subject Matter Experts (SMEs),or serve as SME on local and/or global processes and documents to provide answers or interpretation via training or communication
Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV) and provide appropriate support to fulfil the legal responsibilities.

2. Create solutions to meet customer unmet needs and to enhance product value from safety viewpoints

Provide consultation support to enhance product value and to secure/increase the quality of our deliverables
Make technical decisions to solve technical, operational and business problems which impact on Japan and/or other regions PV activities
Collaborate with other appropriate functions which can catch customer needs to identify their insights and develop solutions to answer their medical/safety needs with our safety expertise.
Input on safety matters in the appropriate internal business planning process, and lead discussion to create evidence based on safety data which may meet customer needs and fulfill patient insights from company-wide view points

3. Develop and maintain safety technical capabilities

Accelerate innovations which may have an impact on internal PV activities to improve our efficiency and to increase value of our outputs in order to answer our customers’ expectations
Contribute to build and improve operational systems to achieve efficient pharmacovigilance activities
Contribute to global functions actively, especially Surveillance and Risk Benefit Balance teams, participating as an expert in JP safety management and to influence them appropriately on behalf of Japan safety
Share and enhance product/therapeutic expertise in addition to safety regulations with safety colleagues by providing learnings and individual technical coaching
Develop and maintain safety technical capabilities as safety organization through technical coaching in projects(OJT), training sessions (Off JT) and knowledge management framework establishment.
Contribute to organizational transformation and demonstrate leadership to accelerate changes.

4. People management/development

Support people development and foster staff
Coach staff by providing timely constructive feedback and recognition to good results and behaviors.
Demonstrate a leadership behavior and be a role model of Team

Business Title: Associate Director/Director-GPSS

応募条件

【必須事項】
Minimum Qualification Requirements:
・Strong knowledge of Global and local regulatory requirements
・Experience of safety planning/management and pharmacovigilance(over 5 yrs)
・Experience of pharmaceutical industry activities/policy activities for environmental shaping
・Strong communication and negotiation skill in both of English and Japanese
・Project management skill and experience
・English and Japanese fluency; excellent oral and written skills required
・B.S. degree in a pharmaceutical, scientific or medical field

Other Information/Additional Preferences:
・Have experiences of Safety, Post marketing study, Medical Information, Development, Clinical Trial, Regulatory, Medical, Quality or Audit
・Requires technical knowledge and understanding of the business linkages and drivers outside of business area;
・Have business acumen
・Makes decisions guided by policies, procedures and business plan that impact the level of customer service and the work unit’s ability to meet performance objectives
・Influences internal and external customers and management
・Identifies and solves a range of organizational and operational problems and technical challenges
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】兵庫県

年収・給与

経験により応相談