Senior Global Risk Management Plan Director
hace 3 días
The Senior Global Risk Management Plan Manager will guide the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management. This includes strategic support to new submissions and innovative products. The successful candidate will provide support to the Safety Lead in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans (RMP) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner.
Key Responsibilities- Drive the development of a robust and feasible RMP strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT, including for new submissions and innovative medicines, aligned with business priorities.
- Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrixes.
- Lead initiatives related with Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.
- Represent the RM function in the Safety management team, works in close collaboration with the Safety Lead, Regulatory and other team members of the SMT/GPT (Clinical, Medical Affairs, Epidemiology, Biostatistics, Clinical Pharmacology, and Marketing, etc.) for the risk minimization activities planning and defining of effectiveness, including for new submissions and innovative medicines.
- Partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs.
- Mentor new hires in the AR &RM team as RMP expert.
- Deputizes for the Team Lead or Group Head AR&RM in defined meetings and initiatives.
- At least 7 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs, with 3 or more years expert knowledge in safety risk management.
- Proven ability to work with large cross-functional teams in complex projects, including new submissions and innovative medicines. Has demonstrated teamwork and effective communication skills. Partners with other line functions and establishes effective relationships with stakeholders at all levels.
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Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will guide the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management, including strategic support to new submissions and innovative products.This role will provide...
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Senior Global Risk Management Plan Director
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will guide the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management, including strategic support to new submissions and innovative products.This role will provide...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, 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 ResponsibilitiesDevelop and implement Risk Management...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, 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 ResponsibilitiesDevelop and implement Risk Management...
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Senior Global Risk Management Plan Manager
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will guide the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, including strategic support to new submissions and innovative products.This role will provide support to the Safety Lead in the management,...
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Senior Global Risk Management Plan Manager
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will guide the Safety Lead and the SMT/GPT on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, including strategic support to new submissions and innovative products.This role will provide support to the Safety Lead in the management,...
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Senior Global Risk Management Plan Manager
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will lead the development of a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, in collaboration with the Safety Lead and the SMT/GPT. This includes new submissions and innovative medicines, aligned with business priorities.The successful...
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Senior Global Risk Management Plan Manager
hace 3 días
Madrid, Madrid, España Novartis A tiempo completoAbout the RoleThe Senior Global Risk Management Plan Manager will lead the development of a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, in collaboration with the Safety Lead and the SMT/GPT. This includes new submissions and innovative medicines, aligned with business priorities.The successful...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoJob SummaryWe 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 Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.Key ResponsibilitiesLead a team of Senior...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Mygwork A tiempo completoJob SummaryWe 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 Risk Management Plan strategies and Aggregate Reports for assigned high-priority products/therapies.Key ResponsibilitiesLead a team of Senior...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Novartis 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 ARRM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Key ResponsibilitiesTimely delivery of high-quality Risk...
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Global Risk Management Lead
hace 3 días
Madrid, Madrid, España Novartis 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 ARRM Analysts in developing robust and feasible Risk Management Plan strategies and Aggregate Reports for high-priority products/therapies.Key ResponsibilitiesTimely delivery of high-quality Risk...
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Senior Director Quality Management
hace 4 semanas
Madrid, Madrid, España Gsk A tiempo completo{"title": "Senior Director Quality Management", "content": "Job SummaryGSK is seeking a Senior Director Quality Management to partner with the Global Health Leadership team to develop and deliver an effective Quality and Risk Management Program for the Global Health Unit. The successful candidate will have a broad scientific/pharmaceutical industry...
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Senior Director Quality Management
hace 4 semanas
Madrid, Madrid, España Gsk A tiempo completo{"title": "Senior Director Quality Management", "content": "Job SummaryGSK is seeking a Senior Director Quality Management to partner with the Global Health Leadership team to develop and deliver an effective Quality and Risk Management Program for the Global Health Unit. The successful candidate will have a broad scientific/pharmaceutical industry...
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hace 4 semanas
Madrid, Madrid, España Global A tiempo completoAbout the RoleThis is a challenging opportunity to join S&P Global's Analytic Risk & Quality (ARQ) team as an Associate Director: Analytic Risk Officer. As a key member of the team, you will be responsible for providing an independent, risk-based assessment of the inherent risks of various analytic products produced by Sustainable1 (S1) and the robustness of...
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