Group Head, Global Aggregate Reports
hace 4 semanas
.Job ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.About the RoleThe Group Head, Global Aggregate Reports & Risk Management, leads a group of Senior Global Risk Management Plan Managers as well as Senior Medical Writers and AR&RM Analysts 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 complex stakeholder matrixes.Your key responsibilities include:Responsible for timely high-quality deliverables either through direct involvement in processes or through assignments considering 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 adequate resource allocation.Responsible for recruiting, developing, and 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.Member of the AR&RM Leadership Team. Collaborates with the Global Head Aggregate Reports & Risk Management in setting and achieving department objectives.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.Acts as AR&RM Subject Matter Expert (SME) in inspections and audits, including handling pre-inspection/audit requests and participating in interviews with inspectors/auditors.Acts as AR&RM SME for assigned collaborations at early stages of partnerships, influencing collaborations beyond Patient Safety.Represents AR&RM in MSRB, GLC, GPTs & SMTs 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
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Group Head, Global Aggregate Reports
hace 4 meses
Barcelona, España Novartis A tiempo completo**Summary**: Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, España Novartis A tiempo completo.SummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling....
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Group Head, Global Aggregate Reports
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completo.Job ID REQ-10011542Aug 29, 2024SpainSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, España Innovative Medicines A tiempo completo.SummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling....
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Group Head, Global Aggregate Reports
hace 1 semana
Barcelona, España Novartis A tiempo completoSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.Participates in the resolution of any legal liability and in complying with government regulations.Ensures accurate receipt, maintenance and assessment against product labeling.Reports...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, España Novartis A tiempo completoSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.Participates in the resolution of any legal liability and in complying with government regulations.Ensures accurate receipt, maintenance and assessment against product labeling.Reports...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, España Novartis A tiempo completoSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling....
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, España Novartis A tiempo completoSummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling....
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Group Head, Global Aggregate Reports
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt,...
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Group Head, Global Aggregate Reports
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt,...
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Global Head, Aggregate Reports and Risk Management
hace 2 semanas
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 2 semanas
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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Group Head, Global Aggregate Reports
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummary Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt,...
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Group Head, Global Aggregate Reports
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Date: Aug 29, 2024Location: SpainSummaryMonitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt,...
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Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Aug 29, 2024SpainSummary: Monitors and audits the company's drug, biologics, or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance, and...
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Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Aug 29, 2024SpainSummary: Monitors and audits the company's drug, biologics, or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports.Participates in the resolution of any legal liability and in complying with government regulations.Ensures accurate receipt, maintenance, and...
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Group Head, Global 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, 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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Group Head, Global 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, 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, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542 Aug 29, 2024 Spain Summary: Monitors and audits the company's drug, biologics, or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports.Participates in the resolution of any legal liability and in complying with government regulations.Ensures accurate receipt, maintenance, and...
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Barcelona, España Novartis Farmacéutica A tiempo completoJob ID: REQ-10011542Aug 29, 2024SpainSummary: Monitors and audits the company's drug, biologics, or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance, and...
