Director Global Pharmacovigilance

hace 2 semanas


Centro, España Teva A tiempo completo
Director Global Pharmacovigilance - Safety Physician

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.

#J-18808-Ljbffr

  • Centro, 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...


  • Centro, España Tevapharm A tiempo completo

    Director Global Pharmacovigilance - Safety Physician Date: Sep 23, 2024 Location: Madrid, Spain, 28108 Job Id: 58386 Together, 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...


  • Centro, España Teva A tiempo completo

    Director 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,...

  • Global Business Director

    hace 3 semanas


    Centro, España Mindshare World A tiempo completo

    GroupM es la compañía matriz que gestiona las inversiones de medios de WPP. Las agencias de medios de GroupM incluyen a Mindshare, EssenceMediaCom, Wavemaker, Mediterránea y T&Pm, cada una de ellas con operaciones globales y posiciones líderes en el mercado.Buscamos un/a Global Business Director para unirse a nuestro equipo global y liderar proyectos...

  • Global Business Director

    hace 3 semanas


    Centro, España Mindshare Spain SA A tiempo completo

    GroupM es la compañía matriz que gestiona las inversiones de medios de WPP. Las agencias de medios de GroupM incluyen a Mindshare, EssenceMediaCom , Wavemaker, Mediterránea y T &P m , cada una de ellas con operaciones globales y posiciones líderes en el mercado. Buscamos un/a Global Business Director para unirse a nuestro equipo global y...

  • Global Business Director

    hace 2 semanas


    Centro, España Mindshare World A tiempo completo

    GroupM es la compañía matriz que gestiona las inversiones de medios de WPP. Las agencias de medios de GroupM incluyen a Mindshare, EssenceMediaCom, Wavemaker, Mediterránea y T&Pm, cada una de ellas con operaciones globales y posiciones líderes en el mercado. Buscamos un/a Global Business Director para unirse a nuestro equipo global y liderar proyectos...

  • Global Business Director

    hace 2 semanas


    Centro, España Mindshare Spain SA A tiempo completo

    GroupM es la compañía matriz que gestiona las inversiones de medios de WPP. Las agencias de medios de GroupM incluyen a Mindshare, EssenceMediaCom , Wavemaker, Mediterránea y T &P m , cada una de ellas con operaciones globales y posiciones líderes en el mercado. Buscamos un/a Global Business Director para unirse a nuestro equipo global...


  • Centro, España Viatris A tiempo completo

    Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via : Access Providing high quality trusted medicines...


  • Centro, España Amadeus A tiempo completo

    Job Title Director of Global Marketing - Travel Unit Summary Your purpose as a Global Marketing Director is to inspire our customers to achieve their ambitions with the support of Amadeus. You will lead the central marketing function for all of Amadeus’ Travel Unit, driving global marketing activities, defining strategies, and managing customer...


  • Centro, España Zoomcar A tiempo completo

    Who we are 80% of the workers across the globe are Deskless. These are the people who keep our lights on and gas flowing, build roads and bridges, run our manufacturing factories, ensure that we get healthcare service, and provide us reliable phone and internet connectivity. As entrepreneurs, have we considered solving their problems and making them more...

  • Global Biddable Executive

    hace 3 semanas


    Centro, España Havas Media Group Spain SAU A tiempo completo

    Global Biddable ExecutiveApplyRemote Type: HybridLocations: MadridTime Type: Full timePosted On: Posted 30+ Days AgoJob Requisition ID: JR0073564Agency: Artemis AllianceJob Description Summary: The CoE Trading Executive supports both the Global CoE Trading Excellence Director and the Global CoE Managing Director to establish and ensure the success of the CoE...

  • Global Biddable Executive

    hace 2 semanas


    Centro, España Havas Media Group Spain SAU A tiempo completo

    Global Biddable Executive Apply Remote Type: Hybrid Locations: Madrid Time Type: Full time Posted On: Posted 30+ Days Ago Job Requisition ID: JR0073564 Agency: Artemis Alliance Job Description Summary: The CoE Trading Executive supports both the Global CoE Trading Excellence Director and the Global CoE Managing Director to establish and ensure the...


  • Centro, España Insud Pharma A tiempo completo

    Who we are? Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous...


  • Centro, España Cabify A tiempo completo

    ¿Quieres cambiar el mundo? Eso es lo que hacemos en Cabify. Nuestro objetivo es hacer de las ciudades mejores lugares para vivir, mejorando la movilidad de las personas que viven en ellas, conectando a pasajeros y conductores con tan sólo pulsar un botón. Es posible que algún día las ciudades sean lugares donde nadie necesite un coche privado, pero...

  • Global Sales Director

    hace 3 semanas


    Centro, España Page Executive A tiempo completo

    International Fashion CompanyGreat opportunity to grow up professionallyAbout Our ClientInternational Fashion company (multichannel).Job DescriptionReporting directly to the CEO, the GSD will:Define the global sales strategy of the company, broken down into different sales channels.Lead the whole commercial team for each department.Lead the growth and...


  • Centro, España Celonis A tiempo completo

    ```html We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. The Team: The Celonis Value Engineering (VE) team is focused on...


  • Centro, España https:www.energyjobline.comsitemap.xml A tiempo completo

    We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. The Team: The Celonis Value Engineering (VE) team is focused on managing...


  • Centro, España Michael Page ES A tiempo completo

    Treasury Director. Multinational company. BilbaoWe are looking for a Treasury Director based in Bilbao. Reporting to the VP Corporate Finance, the Treasury Director will lead the Treasury function, defining the treasury and financing long-term strategy as well as the short-term goals.This is an exciting role for a treasury senior professional to lead a team...


  • Centro, España https:www.energyjobline.comsitemap.xml A tiempo completo

    We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. The Team: The Celonis Value Engineering (VE) team is focused on managing...

  • Business Unit Director

    hace 3 semanas


    Centro, España Michael Page A tiempo completo

    Business Unit Director|Definición de la estrategia de ventaCompañía global en el entorno servicios profesionales TIC.Dirección del negocio de la Unidad de Negocio del Grupo (Unidad de Servicios y Soluciones IT & Digital basados en perfiles y equipos tecnológicos).Definición de la estrategia de venta, así como de los objetivos del equipo. Habrá de...