Global Program Safety Lead
hace 1 mes
.Job Description Summary-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.Job DescriptionGlobal Program Safety Lead – Immunology **Two positions available**Primary Location: London, United Kingdom Alternate Location(s): Barcelona or Madrid, Spain Working model: All locations have a hybrid working model (which requires 12 days per month in the office)Note: Novartis is not able to offer relocation support for this role. Please only apply if the location is accessible for you.About this role: Our Global Program Safety Lead excels as a scientific safety leader within the Immunology 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.Role Requirements:Medical Degree required8+ years of experience in Big PharmaSkills: Clinical Research.Clinical Trials.Functional Teams.Leadership.Medical Strategy.Process Safety Management.Regulatory Compliance.Risk Management.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
Madrid, Madrid, España Novartis A tiempo completoGlobal Program Safety Lead - ImmunologyAt Novartis, we are seeking a highly skilled Global Program Safety Lead to excel as a scientific safety leader within our Immunology Medical Safety organization.About the role:Our Global Program Safety Lead will be responsible for designing and developing safety surveillance strategies for products and approvals. They...
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Global Program Safety Lead
hace 1 mes
Madrid, Madrid, España Novartis A tiempo completoJob Description:As a Global Program Safety Lead at Novartis, you will be responsible for designing and developing safety surveillance strategies for products and approvals. This includes overseeing the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. You will also be responsible...
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Global Program Safety Lead
hace 1 mes
Madrid, Madrid, España Novartis A tiempo completoJob DescriptionAs a Global Program Safety Lead, you will be responsible for designing and developing safety surveillance strategies for products and approvals. You will oversee the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. You will also be responsible for safety in clinical...
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Global Program Safety Lead
hace 1 mes
Madrid, España Novartis A tiempo completoJob Description Summary-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...
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Pharmacovigilance Director
hace 1 semana
Madrid, Madrid, España Teva A tiempo completoDirector Global Pharmacovigilance Role:As a Director of Global Pharmacovigilance, you will play a pivotal role in leading the safety profile of assigned products during clinical development. This includes Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. You will collaborate with other R&D teams to...
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Global Pharmacovigilance Lead
hace 2 semanas
Madrid, Madrid, España Tevapharm A tiempo completoDirector Global PharmacovigilanceWe're seeking a skilled Safety Physician to join our Medical Scientific Unit (MSU) and lead drug safety across the entire Teva portfolio.As a Safety Physician, you'll work closely with cross-functional teams to identify and define the risks of our drugs and propose measures to minimize or mitigate them.Key...
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Global Safety Director
hace 4 semanas
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoTeva Pharmacovigilance - A Leader in Safety SolutionsAs a key member of our Medical Scientific Unit (MSU), the Director Global Pharmacovigilance will play a pivotal role in leading drug safety across our entire portfolio and product lifecycle. Collaborating with other Teva stakeholders, our MSU safety physicians and scientists will identify and define risks...
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Senior Safety Project Lead
hace 5 meses
Madrid, España Novasyte A tiempo completoSenior Safety Project Lead will be responsible for management and service delivery excellence for assigned projects, covering post-market products. You will provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery...
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Svp, Global Patient Safety
hace 1 mes
Madrid, España Alnylam Pharmaceuticals Inc. A tiempo completo.Job Description - SVP, Global Patient Safety & Risk Management (230666)Overview The Senior Vice President of Global Patient Safety & Risk Management will be responsible for leading and scaling a Drug Safety/Risk Management/Pharmacovigilance function commensurate with company P^5x25 goals and strategic priorities. The Senior Vice President GPSRM role reports...
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Director Global Pharmacovigilance
hace 4 semanas
Madrid, 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...
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Director Global Pharmacovigilance
hace 7 horas
Madrid, 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...
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Director Global Pharmacovigilance
hace 2 meses
Madrid, España Tevapharm A tiempo completo.Director 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...
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Director Global Pharmacovigilance
hace 3 semanas
Madrid, España Teva A tiempo completoDirector Global Pharmacovigilance - Safety PhysicianLead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. Collaborate with other R&D teams to ensure execution of the safety strategy.Contribute to clinical documents,...
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Svp, Global Patient Safety
hace 3 meses
Madrid, España Alnylam Pharmaceuticals Inc. A tiempo completoJob Description - SVP, Global Patient Safety & Risk Management (230666)Overview The Senior Vice President of Global Patient Safety & Risk Management will be responsible for leading and scaling a Drug Safety/Risk Management/Pharmacovigilance function commensurate with company P^5x25 goals and strategic priorities. The Senior Vice President GPSRM role reports...
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Director Global Pharmacovigilance
hace 2 meses
Madrid, España Teva Pharmaceuticals A tiempo completoThe opportunityTeva Pharmacovigilance unit is hiring a physician for the Safety physician, Director Pharmacovigilance role to join the Medical Scientific Unit (MSU) and support safety in projects under development. In this unit we lead drug safety across the entire Teva portfolio and throughout the product lifecycle. In partnership with other Teva...
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Medical Safety Lead
hace 1 mes
Madrid, España Thepharmadaily A tiempo completoMonitor the clinical safety of projects/products through activities such as literature reviews, individual case evaluations, and signal detection; respond appropriately to safety-related inquiries.Conduct medical assessments for cases as needed, including collecting follow-up information, evaluating product quality defects related to adverse events,...
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Global Inventory Program Lead
hace 3 semanas
Madrid, Madrid, España Sandoz A tiempo completo**Role Overview**Sandoz is seeking an experienced professional to lead the Inventory Reduction Program, driving end-to-end responsibility for inventory management and reduction. The successful candidate will define key process improvements and projects to achieve aspirational goals, ensuring proper resources and progress. They will also establish clear...
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Global Fire Safety Manager
hace 1 semana
Madrid, Madrid, España ENGINEERINGUK A tiempo completoTechnical Program Manager RoleWe are looking for a highly experienced Technical Program Manager to lead our fire protection engineering programs across Europe, Middle East, and Africa (EMEA) region. The successful candidate will have a strong background in fire protection engineering, project management, and technical program leadership.Key...
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Safety & Labelling Partner Lead
hace 5 meses
Madrid, España Norgine A tiempo completoWant a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether...
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Madrid, Madrid, España Alnylam Pharmaceuticals A tiempo completoAbout Alnylam PharmaceuticalsAlnylam Pharmaceuticals is a leading biotech company dedicated to developing innovative treatments for patients worldwide. Our commitment to excellence drives us to push the boundaries of science and medicine.Job Summary:We are seeking an experienced Senior Vice President of Global Patient Safety and Risk Management to lead our...