Global Head, Aggregate Reports and Risk Management
hace 5 días
The Global Head, Aggregate Reports and Risk Management will lead a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies. This role will be responsible for ensuring alignment with the benefit-risk profile of the products and supported by complex stakeholder matrices.
Key Responsibilities- Responsible for timely high-quality deliverables through direct involvement in processes or through assignments considering individual workload, experience, location, business needs, and individual development needs.
- Interacts with Global Product Teams and Functions to ensure proper prioritization of programs and assign adequate resources.
- Responsible for recruiting, developing, and retaining Senior Global RMP Managers, Senior Medical Writers, and AR&RM Analysts, developing and implementing an onboarding program for new hires.
- Provides operational and strategic guidance on RMP & AR processes, policy, templates, and training.
- Member of the AR&RM Leadership Team, collaborating with the Global Head Aggregate Reports & Risk Management in setting the department's objectives and achieving them.
- Advises and influences the organization regarding Aggregate Reports & Risk Management concepts, strategy, and processes, relevant for product submissions and launches worldwide as well as for lifecycle management.
- Guides 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.
- Acts as AR&RM Subject Matter Expert (SME) in inspections and audits, including handling of pre-inspection/audit requests, participating in interviews with inspectors/auditors, and supporting CAPAs.
- Acts as AR&RM SME for assigned collaborations at early stages of partnerships, influencing these collaborations beyond Patient Safety.
- Represents AR&RM in MSRB, GLC, GPTs & SMTs and other relevant boards/teams and provides expert opinion as required.
- Evaluates the impact and ensures compliance in collaboration with OPEX of worldwide regulations and industry practices on current AR&RM plans strategy, processes, and tools.
- Collaborates with OPEX and the AR&RM office in designing, developing, and maintaining metrics to monitor quality of RMPs & AR, and escalates any potential risk and issues.
- Provides input into the development of regular and up-to-date AR & RM training to the organization.
- Deputizes for the Global Head Aggregate Reports & Risk Management as needed.
- Scientific Degree required. Life sciences degree desirable. Advanced degree (Masters, MD, PharmD or PhD) required.
- Fluent in spoken and written English.
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Global Head, Aggregate Reports and Risk Management
hace 9 horas
Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by...
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Global Head, Aggregate Reports and Risk Management
hace 6 horas
Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head, Aggregate Reports and Risk Management, leads a team of Senior Risk Management and Aggregate Reports Specialists in the development of robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the products and supported by...
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Global Head, Aggregate Reports and Risk Management
hace 9 horas
Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Global Head, Aggregate Reports and Risk Management will lead a team of Senior Risk Management Plan Managers, Medical Writers, and Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products and therapies. This role will align with the benefit-risk profile of products and be...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans (RMPs) and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans (RMPs) and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis Farmacéutica, responsible for overseeing the development and implementation of robust Risk Management Plans and Aggregate Reports for high-priority products and therapies. This role requires a deep understanding of regulatory...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head of Risk Management and Aggregate Reports is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role is critical in ensuring the company's compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Lead a team...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head of Risk Management and Aggregate Reports is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role is critical in ensuring the company's compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Lead a team...
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Global Head of Aggregate Reports and Risk Management
hace 6 horas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role: As the Global Head of Aggregate Reports and Risk Management at Novartis Farmacéutica, you will lead a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies. Your expertise will...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports and Risk Management, leads a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe Group Head, Global Aggregate Reports & Risk Management leads a team of Senior Global Risk Management Plan Managers, Senior Medical Writers, and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies, aligned with the benefit-risk profile of the...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis, responsible for overseeing the development and implementation of robust risk management plans and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements, industry...
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Barcelona, Barcelona, España Novartis A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a critical leadership position within Novartis, responsible for overseeing the development and implementation of robust risk management plans and aggregate reports for high-priority products and therapies. This role requires a deep understanding of regulatory requirements, industry...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role requires a deep understanding of global regulatory requirements and the ability to develop and implement effective risk management strategies.Key...
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Head of Aggregate Reports and Risk Management is a senior leadership position responsible for leading a team of experts in risk management and regulatory affairs. This role requires a deep understanding of global regulatory requirements and the ability to develop and implement effective risk management strategies.Key...
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Barcelona, Barcelona, España Mymenopauserx A tiempo completoJob SummaryMymenopauserx is seeking a highly experienced Senior Medical Director to lead our Global Patient Safety and Risk Management efforts. As a key member of our team, you will be responsible for providing strategic and operational oversight of our Safety Surveillance and Risk Management activities.Key ResponsibilitiesDevelop and execute a comprehensive...
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