Svp, Global Patient Safety
hace 1 mes
.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 directly to the Chief Development Officer, reflecting our regard for the centrality of drug safety in all that we do. The successful applicant will have the ability to develop strategy and grow the Drug Safety Expertise Area, while remaining very hands-on like smaller biotech culture. He/she will be a key member of the R&D team and work in a vibrant culture, thriving on science, passion, and urgency.Key Responsibilities Be the senior strategic and operational leader providing a strong, clear voice for the drug safety program and have a clear next-generation vision for Global Patient Safety and Risk Management.Grow, direct, and support the operations of a global function supporting products from initial IND/CTA, through NDA/MAA filings, to approval and post-marketing.Develop a platform-wide view of safety with the ability to integrate safety across disparate products that share common chemistries.Ensure all relevant SOPs and systems/processes are in place making for an efficient and compliant organization.Develop creative but realistic approaches to drug safety and lead efforts to secure global regulatory approvals.Provide strategic consultation and guidance on all decisions that have significant drug safety implications.Supervise closely major written deliverables (all regulatory submissions [NDA/MAA safety sections and CCDS/RMP, PSUR, DSUR, PBRER], original articles, abstracts), and presentation materials.Be responsible for final review and sign-off with respect to all controlled documents.Be accountable for all relevant timelines and deliverables.Influence internal and external audiences in a high-impact, highly visible fashion.Be the lead alliance partner on all aspects of drug safety.Ability to build and lead a drug safety team to support the current and future Alnylam pipeline and product launches.Qualifications MD, PhD or equivalent.10+ years of industry experience.Experience working in a fast-paced environment and building and growing teams.Direct knowledge and experience of major filings such as IND, CTA, NDA, and MAAs.Experience in developing systems and processes for handling, processing, analysis, and regulatory reporting of adverse event reports, including serious adverse events.Managing all aspects of post-marketing product safety in US, EU, and other major territories.Has managed drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls/withdrawals, and safety-related label changes
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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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Senior Manager, Global Patient Safety Scientist
hace 2 meses
Madrid, España Regeneron A tiempo completoSUMMARY:We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area. This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.As...
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Madrid, Madrid, España Alnylam Pharmaceuticals Inc. A tiempo completoJob Description: As the Senior Vice President of Global Patient Safety and Risk Management at Alnylam Pharmaceuticals Inc., you will be responsible for leading and scaling a Drug Safety/Risk Management/Pharmacovigilance function that aligns with the company's strategic priorities. This role reports directly to the Chief Development Officer, reflecting the...
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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...
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Nurse Specialist for Patient Safety
hace 1 semana
Madrid, Madrid, España Woodston Personnel Ltd. A tiempo completoOverview:Woodston Personnel Ltd. is seeking a skilled Clinical Resource Nurse to join our team in Saudi Arabia. This exciting opportunity allows you to contribute to the delivery of high-quality patient care while fostering a culture of excellence and safety within the healthcare setting.
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Global Safety Strategist for Ophthalmology
hace 2 semanas
Madrid, Madrid, España Regeneron A tiempo completoJob SummaryWe are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk...
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Global Safety Writer
hace 1 semana
Madrid, Madrid, España Baxter A tiempo completoRole OverviewWe are seeking a skilled Global Safety Writer to join our team at Baxter. As a key member of our regulatory affairs department, you will play a vital role in ensuring the safety and compliance of our pharmaceutical products worldwide.
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Senior Health
hace 6 meses
Madrid, España Edwards Lifesciences A tiempo completoInnovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring.With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.Our...
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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 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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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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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 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 completo.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...
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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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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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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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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 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 9 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...