Global Aggregate Reports and Risk Management Leader
hace 2 semanas
The Group Head, Global Aggregate Reports & Risk Management, leads a team of Senior Global Risk Management Plan Managers and 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 products and supported by complex stakeholder matrices.
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.
- Interacts with GPTs and Functions (e.g., GPH, HPS, Medical Writing, Regulatory Affairs) to ensure proper prioritization of programs and assign adequate resources.
- Aligns 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.
- Provides 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.
- Collaborates with 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 by close connection with stakeholders and industry peers.
- 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, e.g., integrations, mergers, and acquisitions, influencing these collaborations beyond Patient Safety, in global and local cross-functional and cross-divisional aspects of RMP, e.g., Regulatory Affairs, Marketing, Countries, which impact worldwide launches.
- 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, e.g., ensures the templates and internal guidance on strategy are in accordance with new/changing regulations.
- Drives the internal alignment on the company position with multiple functions and boards involved.
- Oversees the Global Teams' strategies for AR & RMP related responses to Health Authorities.
- In collaboration with OPEX and the AR&RM office, designs, develops, and maintains metrics to monitor quality of RMPs & AR, and escalates to Head of department, QPPV, PS&PV leadership, and cross-functional boards any potential risk and issues.
- Provides input into the development of regular and up-to-date AR & RM training to the organization (namely SMT/GPTs, Medical Safety, Regulatory, Quantitative Safety and Epidemiology, Clinical, Medical Affairs).
- Deputizes for the Global Head Aggregate Reports & Risk Management, e.g., MSRB for AR & RMP related aspects, and strategic initiatives.
- Deputizes for other Group head when required, supporting their team.
- 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 Aggregate Reports and Risk Management Leader
hace 1 semana
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 and Senior Medical Writers in developing robust Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Your Key Responsibilities Include:Developing and implementing Risk Management Plan...
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Global Head of Aggregate Reports and Risk Management
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob SummaryThe Global Head of 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.Key ResponsibilitiesDevelop and implement Risk Management...
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoAbout the RoleThe 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...
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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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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 Head of Aggregate Reports and Risk Management
hace 1 semana
Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Title:Global Head of Aggregate Reports and Risk ManagementAbout the Role:The Global Head of 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 assigned high-priority...
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Group Head, Global Aggregate Reports and Risk Management
hace 1 semana
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 high-priority products/therapies.Key Responsibilities:Responsible for timely high-quality...
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Global Head of Aggregate Reports and Risk Management
hace 1 semana
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 high-priority products/therapies, aligned with the benefit-risk profile and supported by...
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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 and 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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Global Head of Aggregate Reports and Risk Management
hace 2 semanas
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 and 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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Global Head of Aggregate Reports and Risk Management
hace 2 semanas
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 and 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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Global Head of Aggregate Reports and Risk Management
hace 2 semanas
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 and 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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hace 1 semana
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Barcelona, Barcelona, España Innovative Medicines A tiempo completoJob Title: Group Head, Global Aggregate ReportsAbout the Role: We are seeking a highly skilled and experienced professional to lead our Global Aggregate Reports Risk Management team. As the Group Head, you will be responsible for developing and implementing robust and feasible Risk Management Plan strategies and Aggregate Reports for assigned high-priority...
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Global Risk Management Lead
hace 1 semana
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 and Senior Medical Writers and AR&RM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Key Responsibilities:Develop and implement Risk...
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