Director Global Pharmacovigilance
hace 3 semanas
Lead 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, such as protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety-related clinical documents.
Lead and chair the cross-functional Product Safety Group. Be responsible for presenting decisions from the Product Safety Group to senior governance committees and Teva’s top management.
Perform medical review of ICSRs for assigned products from clinical trials.
Accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other products.
Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans throughout the product’s life cycle.
Represent PV on the cross-functional Product Label Working Group. Lead evaluation and determination of safety-related sections of the product label, both initial and throughout the product lifecycle; key member for safety-related label negotiations with regulatory agencies as well as in the development of internal CCSI.
Guide, provide support, and train, as applicable, PV scientists across safety surveillance activities such as medical review, signal detection, and risk evaluation activities.
Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, Quality, etc.) and outside Teva (KOLs, CROs, etc.) to effectively communicate PV position on any safety concerns as well as the overall safety profile of assigned products.
Support global launch activities for assigned products.
Perform due diligence on product safety profile of potential new assets.
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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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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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Director Global Pharmacovigilance
hace 1 día
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 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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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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Senior Pharmacovigilance Director
hace 3 semanas
Madrid, Madrid, España Parexel A tiempo completoAbout the RoleParexel is seeking an experienced Senior Pharmacovigilance Director to join our team. As a key member of our Safety Services Leadership, you will be responsible for providing strategic inputs to the department and organization.Key ResponsibilitiesRepresent the function/department at various internal and external forumsContribute significantly...
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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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Global Pharmacovigilance Director
hace 1 mes
Madrid, Madrid, España Tevapharm A tiempo completoJob OverviewAt Tevapharm, we're committed to making good health more affordable and accessible. As a key member of our Medical Scientific Unit (MSU), you'll play a crucial role in leading drug safety across our entire portfolio and throughout the product lifecycle. In this dynamic and collaborative environment, you'll work closely with other stakeholders to...
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Director Global Pharmacovigilance
hace 1 mes
Madrid, España Teva Pharmaceutical Industries A tiempo completo.Who we areTogether, 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 and backgrounds. Working here means working with the world's leading manufacturer of generic...
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Pharmacovigilance Associate
hace 6 meses
Madrid, España BAXTER A tiempo completo**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
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Pharmacovigilance Specialist
hace 1 mes
Madrid, Madrid, España Viatris A tiempo completoAt Viatris, we empower people worldwide to live healthier at every stage of life. As a Pharmacovigilance Technician, you will play a vital role in maintaining and continuously improving our pharmacovigilance system at the PV Department in Spain.**Key Responsibilities:*** Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and...
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Senior Medical Director
hace 3 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
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Senior Medical Director
hace 3 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
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Business Development Manager
hace 5 meses
Madrid, España PVpharm A tiempo completoPVpharm is searching for a Business Development Manager in Pharmacovigilance Services to work closely with PVpham’s team. This position requires documented experience in Business Development areas related to the Pharma industry (Service provider experience is preferred, and experience with Pharmacovigilance Services would be perfect), organizational and...
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Project Director
hace 5 meses
Madrid, España PrimeVigilance A tiempo completo**Company Description** Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility...
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Global Aviation Supply Chain Director
hace 4 semanas
Madrid, Madrid, España Dsj Global A tiempo completoGlobal Aviation Supply Chain DirectorAt Dsj Global, we are seeking a seasoned Global Aviation Supply Chain Director to lead the coordination of complex logistics operations within the aviation sector.This strategic role requires a deep understanding of end-to-end supply chain management and the ability to identify opportunities for improvement.Key...
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Pharmacovigilance Specialist
hace 2 semanas
Madrid, España Pharmalex A tiempo completoWe are growing, grow with us!Are you looking for a dynamic company with daily new challenges and opportunities?Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action...
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Pharmacovigilance Project Manager
hace 6 meses
Madrid, España PrimeVigilance A tiempo completoCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
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Pharmacovigilance Project Manager
hace 4 meses
Madrid, España PrimeVigilance A tiempo completo**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...