国际药物警戒系统主任
Associate Director. ICSR
我们是PrimeVigilance(Ergomed PLC旗下公司),一家成立于2008年的专业中型药物警戒服务提供商。我们自豪地实现了年复一年的全球有机增长,员工遍布欧洲、北美和亚洲,提供以下服务:医学信息、药物警戒、法规事务和质量保证。
PrimeVigilance为从小型到大型的制药和生物技术合作伙伴提供一流的支持,保持长期合作关系,并已成为该领域的全球领导者。我们覆盖所有治疗领域,包括医疗设备。
我们通过提供优秀的培训和发展平台来投资员工。我们重视员工体验、福祉和心理健康,并认识到健康的工作与生活平衡是员工满意度的关键因素,从而营造出高质量客户服务体系的环境。
加入我们,共同开启这段激动人心的旅程,为患者的生活带来积极影响。
- 有效管理指定的ICSR管理单元
- 确保ICSR项目团队具备足够的资源,以实现最大化的生产力和利用率
- 为持续进行的项目设定生产力目标,并根据需要审查和更新目标
- 根据报告和分析,确定ICSR管理单元内适当的资源重新分配,或与其他单位和部门的资源调配单位合作进行资源调配
- 管理ICSR主管/线经理,确保所有员工得到充分使用和高效工作,并在必要时将员工重新分配给其他ICSR主管/团队
- 如果无法内部管理资源,通知资源部门关于指定项目团队增加资源的需求,在获得批准和预算确认后正式提交请求
- 向ICSR领导层提出项目团队流程中的必要变更
- 寻找解决方案并引入最佳实践,以提高ICSR管理单元内的生产力和利用率
- 对ICSR线经理和高级员工进行培训和指导
- 准备各种分析和报告
- 审核所有新项目的预算和资源分配,以及现有项目的新增工作范围,并支持项目经理总监,视情况而定
- 在合同和方案开发过程中支持业务/商业团队,视情况而定
查看英文原文
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
- Managing the assigned ICSR Management Unit effectively
- Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation
- Setting productivity targets for ongoing projects and reviewing proposed target updates as required
- Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments
- Managing ICSR Leads/Line Managers to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Leads/teams as necessary
- Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations
- Proposing the necessary changes within the project team processes to ICSR leadership
- Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit
- Training and mentoring of ICSR Line Managers and senior staff.
- Preparing various analyses and reports
- Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable
- Supporting the Business/Commercial team during development of contracts and proposals, as applicable
- Supporting the Operations and Project Analytics team, as applicable
- Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities
- Reviewing and approving all Critical CAPAs from the ICSR Management Unit
- Reviewing and addressing any requests from Quality department regarding ICSR Management Unit
- Reviewing and updating PrimeVigilance operating procedures and guidelines, as applicable
- Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
We expect:
· Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
· 6-7 years of work experience in pharmacovigilance within which 2-3 years of work experience in line manager role
· Excellent communication (written and verbal) skills
· Excellent organization skills, including attention to details and multitasking
· Excellent management skills, including delegation skills, time and issue management
· Technical skills
· Team working
· English – fluent (spoken, written)
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
· Training and career development opportunities internally
· Strong emphasis on personal and professional growth
· Friendly, supportive working environment
· Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
· Quality
· Integrity & Trust
· Drive & Passion
· Agility & Responsiveness
· Belonging
· Collaborative Partnerships
We look forward to welcoming your application.