Global Aggregate Reports and Risk Management Lead
hace 4 semanas
The Global Aggregate Reports and Risk Management Lead will be responsible for leading a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies. This role will align with the benefit-risk profile of the products and be supported by complex stakeholder matrices.
Your Key Responsibilities
• Responsible for timely high-quality deliverables through direct involvement in processes or through assignments taking into consideration individual workload, experience, location, business needs, and individual development needs.
• Interact with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
• Align the support provided by Global (Sr) RMP Managers/(Sr) Medical Writers/AR&RM Analysts to the Global teams in developing and maintaining the Safety RMPs, RMP strategy, and Aggregate Reports with business rules, regulatory guidance, and company standard operating procedures.
• Responsible for recruiting, developing, retaining (Sr) Global RMP Managers/(Sr) Medical Writers/AR&RM Analysts, developing, and implementing an onboarding program for new hires.
• Provide operational and strategic guidance on RMP & AR processes, policy, templates, and training.
• Responsible for AR & RM team objectives according to company and department priorities, development plans, and ongoing feedback on performance of direct reports.
• Member of the AR&RM Leadership Team. Collaborate with Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
• Advise and influence the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide as well as for lifecycle management by close connection with stakeholders and industry peers.
• Guide a cross-functional matrix in the development of tools for RMP preparation, implementation tracking, working practices, and guidelines, implementation of regulatory guidance, and Safety RMP project management.
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Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryAs a key member of the Novartis team, the Group Head, Global Aggregate Reports & Risk Management, plays a critical role in ensuring the company's drug, biologics, or medical devices surveillance program is effective and compliant with regulatory requirements. This includes monitoring and auditing adverse reports, participating in the resolution of...
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Global Aggregate Reports and Risk Management Lead
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoKey Responsibilities:As the Group Head of Global Aggregate Reports and Risk Management, you will be responsible for leading a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.You will...
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Global Aggregate Reports and Risk Management Leader
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob SummaryAt Innovative Medicines, we are seeking a highly skilled professional to lead our Global Aggregate Reports & Risk Management team. As the Group Head, you will be responsible for developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.About the RoleThe Group Head, Global...
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Barcelona, Barcelona, España Novartis A tiempo completoJob SummaryAs a Group Head of Aggregate Reports and Risk Management, you will be responsible for leading a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies. You will ensure that these...
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Global Risk Management Lead
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Global Risk Management Lead will lead a team of Senior Global Risk Management Plan Managers and Senior Medical Writers in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.This role requires a strong understanding of regulatory requirements and industry...
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