安全性情報管理（PV）業務 / マネージャー候補
- 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）
- . 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
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