Global Program Safety Lead
hace 4 semanas
.-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams.About the Role Alternate Location(s) : Barcelona, SpainWorking model : Both locations have a hybrid working model (12 days per month in the office)About this role:Our Senior Global Program Safety Lead excels as a scientific safety leader within the Oncology Medical Safety organization.Join us and you will make a significant impact on patients' lives and contribute to Novartis' overall success through robust safety evaluation expertise and medical innovation.Key Responsibilities:Safety Input and Team Participation: Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management.Signal Detection and Safety Management: Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant line functions, post-marketing data, and other sources.Documentation and Record Keeping: Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds.Regulatory and Professional Inquiries: Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues.Safety Strategy Preparation: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members.Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives.Marketing Samples Distribution: Manage the distribution of marketing samples, where applicable.Key performance indicators:Timeliness and quality of safety analyses, interpretations, and presentationCompliance with internal and external regulations & proceduresCompliance, consistency and quality of safety deliverablesRole Requirements:Medical Degree is required10+ years of experience in Big Pharma3 to 5 years Oncology experience.Skills:Clinical Research.Clinical Trials.Functional Teams.Leadership.Medical Strategy.Process Safety Management.Regulatory Compliance.Safety Science.Languages :Fluent English (both spoken and written) is mandatory.Additional languages are an advantage
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Global Program Safety Lead
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completo.-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal...
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Global Program Safety Lead
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completo-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal...
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Global Program Safety Lead
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the Role: We are seeking a highly skilled Senior Global Program Safety Lead to join our Oncology Medical Safety organization at Novartis Farmacéutica. This is an exciting opportunity to make a significant impact on patients' lives and contribute to the company's overall success through robust safety evaluation expertise and medical innovation.
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Global Program Safety Lead
hace 7 meses
Barcelona, España Novartis A tiempo completo395310BR **Global Program Safety Lead**: Spain **About the role** The Global Program Safety Lead successfully serves as scientific safety leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation. You will ensure optimal patient safety for...
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Global Program Safety Lead
hace 4 semanas
Barcelona, España Novartis Farmacéutica A tiempo completo-Designs & develops safety surveillance strategy for products and approval. Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal...
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(Busqueda Urgente) Global Program Safety Lead
hace 3 semanas
Barcelona, España Novartis Farmacéutica A tiempo completo.-Designs & develops safety surveillance strategy for products and approval. Responsible for the company's drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal...
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Global Program Safety Director
hace 3 semanas
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleAs a Senior Global Program Safety Lead at Novartis Farmacéutica, you will play a crucial role in ensuring the safety of our products and contributing to the company's overall success through robust safety evaluation expertise and medical innovation.
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Barcelona, España Amazon A tiempo completo.Road Safety Program Manager, Global Road Safety At Amazon, we are always exploring new opportunities to shape our global business.As a Program Manager, you'll be an essential part of innovating and transforming our processes.You'll take the lead on the design and launch of new programs for our customers and oversee programs that are already running, finding...
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Barcelona, España Amazon A tiempo completo.Road Safety Program Manager, Global Road SafetyAt Amazon, we are always exploring new opportunities to shape our global business.As a Program Manager, you'll be an essential part of innovating and transforming our processes.You'll take the lead on the design and launch of new programs for our customers and oversee programs that are already running, finding...
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Barcelona, España Amazon A tiempo completoRoad Safety Program Manager, Global Road SafetyAt Amazon, we are always exploring new opportunities to shape our global business.As a Program Manager, you'll be an essential part of innovating and transforming our processes.You'll take the lead on the design and launch of new programs for our customers and oversee programs that are already running, finding...
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Road Safety Program Manager, Global Road Safety
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Barcelona, España Amazon A tiempo completoRoad Safety Program Manager, Global Road SafetyAt Amazon, we are always exploring new opportunities to shape our global business. As a Program Manager, you'll be an essential part of innovating and transforming our processes. You'll be taking the lead on the design and launch of new programs for our customers. You'll also oversee programs that are already...
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Barcelona, España Amazon A tiempo completoRoad Safety Program Manager, Global Road SafetyAt Amazon, we are always exploring new opportunities to shape our global business.As a Program Manager, you'll be an essential part of innovating and transforming our processes.You'll take the lead on the design and launch of new programs for our customers and oversee programs that are already running, finding...
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Global Pharmaceutical Safety Expert Lead
hace 3 días
Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoJob Description-Designs and develops a comprehensive safety surveillance strategy for pharmaceutical products and ensures compliance with approval regulations.-Responsible for overseeing the company's drug surveillance program, including necessary follow-up, risk assessment, and analysis of adverse reaction reports.-Participates in resolving legal liability...
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Global Health
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Patient Safety Lead
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Global Clinical Program Lead, Late Stage
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hace 15 horas
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Patient Safety Lead | Vmg410
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Barcelona, España Morgan Philips Executive Search A tiempo completoImportant Pharmaceutical Company is looking for a Patient Safety Lead.Responsibilities : Lead the strategy for proactive PV and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the Global Safety...
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Safety Manager Bcn | Lead Safety Excellence
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Director Global Pharmacovigilance
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Barcelona, España Tevapharm A tiempo completoDirector Global Pharmacovigilance - Safety PhysicianDate: Sep 23, 2024Location: Madrid, Spain, 28108Job Id: 58386Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities...