? (Urgente) Group Head, Global Aggregate Reports & Risk Management
hace 1 semana
.Job Description 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. 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.Job DescriptionThe 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, but not limited to; Responsible for timely high-quality deliverables either 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 (eg. 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's 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's and Safety RMP project management
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Group Head, Global Aggregate Reports
hace 1 semana
Barcelona, España Healthcare Businesswomen’S Association A tiempo completo.Job Description 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...
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Group Head, Global Aggregate Reports
hace 1 semana
Barcelona, España Novartis Farmacéutica A tiempo completo.Job ID REQ-10011542SpainSummary 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...
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Group Head, Global Aggregate Reports
hace 3 semanas
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 completoJob Description 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...
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Group Head, Global Aggregate Reports
hace 1 semana
Barcelona, España Novartis A tiempo completoJob Description 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...
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Group Head, Global Aggregate Reports
hace 1 semana
Barcelona, España Novartis A tiempo completoJob Description 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...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, 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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Barcelona, España Novartis Farmacéutica A tiempo completo.Job ID REQ-10011542SpainSummaryMonitors 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...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob Description 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...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, Barcelona, España Healthcare Businesswomen's Association A tiempo completoJob Description 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...
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Group Head, Global Aggregate Reports
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoJob ID REQ 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 assessment against...
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Head Risk Management
hace 1 semana
Barcelona, España Novartis A tiempo completo.Summary :Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...
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Head Risk Management
hace 1 semana
Barcelona, España Novartis A tiempo completoSummary : Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco - and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...
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Head Risk Management
hace 3 semanas
Barcelona, España Novartis A tiempo completo**Summary**: Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco - and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...
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(Lmu303) | Head Risk Management
hace 1 semana
Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica A tiempo completo.12 jun | ES06 (FCRS = ES006) Novartis Farmacéutica | BarcelonaDrive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards.Establish and maintain the risk...
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Head Risk Management
hace 2 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoResponsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...
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Head Risk Management
hace 2 semanas
Barcelona, Barcelona, España Novartis A tiempo completoSummary:Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...
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Head Risk Management
hace 1 semana
Barcelona, España Novartis Farmacéutica A tiempo completo.Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...
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Global Head Insurance Risk
hace 4 semanas
Barcelona, España Swissport A tiempo completoGlobal Head Insurance Risk Barcelona Barcelona, Catalunya, ES With 300 airports in around 50 countries and a global workforce of 60. 000 employees Swissport is the world's largest provider of ground handling, cargo, and other aviation related services. We are now looking for a Global Head Insurance Risk who will be based in Madrid, Spain. If you want...
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(Lmu303) | Head Risk Management
hace 1 semana
Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica A tiempo completo12 jun | ES06 (FCRS = ES006) Novartis Farmacéutica | Barcelona - Drive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards. - Establish and maintain the risk...
