Global Pharmacovigilance Expert

hace 1 mes


Zaragoza, Zaragoza, España Pharmalex Gmbh A tiempo completo

We are a dynamic and growing company, offering exciting career opportunities. If you are looking for a challenging role with daily new experiences, then Pharmalex Gmbh is your perfect match. As a leading service company for the Pharmaceutical Industry globally, we specialize in all aspects of drugs and medical devices approval, market development, and effective product maintenance.

**Job Overview:**

  • We are seeking an experienced Global Pharmacovigilance Expert to join our team.

**Job Description:**

The successful candidate will be responsible for:

  1. Providing professional leadership and pharmaceutical expertise to clients in the field of pharmacovigilance.
  2. PER Operational Support as:
    1. Local Literature Surveillance: Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases, and relevant information.
    2. Screening results of EMA Medical Literature Monitoring (MLM) and L2A.
    3. Local literature management through the local PVLit tool.
  3. ICSR Management:
    1. MedDRA and ATC coding of Adverse Drug Reactions and Adverse Events.
    2. Initial processing of incoming information.
    3. Translation of incoming information into English language, including QC.
    4. Data entry into PV database (SafetyEasy or client DB) and/or case tracking system, e.g., Excel.
    5. Initial ICSR assessment, if applicable.
    6. Evaluation of the need for expedited reporting to CAs/Partners of a client concerned, including reporting timelines.
  4. Cosmetovigilance:
    1. Handling all cosmetic products undesirable effects safety information according to the contract established with the Client.
  5. Medical devices:
    1. Handling all medical devices undesirable effects safety information according to the contract established with the Client.
  6. Medical Information:
    1. MI database registration and triage of MI enquiries, AE reports, PQCs, incidents, and non-medical enquiries received via email, fax, or phone.
    2. Management of verbal/written L1 MI enquiries according to approved standard reference documents, e.g., FAQs, SmPC/PIL, SRLs etc., in local language, including translations into English, if needed.
    3. Responding to the L1 MI enquirer, if applicable.
    4. Escalation of L2 MI enquiries to dedicated L2 Support.
    5. Submission of AE reports, PQCs, and incidents to dedicated destinations.
    6. Transfer of L0 non-medical enquiries to dedicated destinations.
    7. Preparation and/or maintenance of the FAQ document and Standard Response Letters (SRLs) including annual update in compliance with the most current Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and relevant regulatory documents.
    8. Management of second-level non-standard and customized MI enquiries, including literature research, if necessary.

**Required Skills and Qualifications:**

  • Bachelor's degree in Life Science or demonstrable experience in Pharmacovigilance.
  • Very good command of English.
  • Autonomous, concentrated, and high-quality work.
  • Ability to work in a team.

**Benefits:**

  • A competitive salary range of €60,000 - €80,000 per annum, depending on experience.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.


  • Zaragoza, Zaragoza, España Pharmalex Gmbh A tiempo completo

    Company OverviewWe are a dynamic and growing company with daily new challenges and opportunities. Pharmalex Gmbh is one of the leading service companies for the Pharmaceutical Industry globally, specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.Job DescriptionAs our Senior...


  • Zaragoza, Zaragoza, España Tevapharm A tiempo completo

    Job SummaryWe are seeking a skilled Safety Physician to lead the pharmacovigilance efforts for our Teva Pharmaceuticals unit. As a key member of the Medical Scientific Unit, you will play a critical role in ensuring the safety and efficacy of our products throughout their lifecycle.About TevaTeva Pharmaceuticals is a leading manufacturer of generic medicines...

  • Global Payroll Expert

    hace 2 semanas


    Zaragoza, Zaragoza, España Tmf Group A tiempo completo

    TMF Group is a leading provider of critical administrative services worldwide. Our team of experts supports multiple international companies with their global entity management, accounting, tax, and payroll needs. We have been present in Spain for over 25 years and continue to grow, with more than 320 colleagues across the country.About TMF GroupWe are a...


  • Zaragoza, Zaragoza, España Schindler Group A tiempo completo

    Transforming Urban MobilitySchindler Group, a global leader in elevator and escalator manufacturing, is seeking a talented Sustainability Reporting Specialist. As a key member of our team, you will play a vital role in shaping the company's sustainability strategy.About UsWe are proud to be one of the world's leading suppliers of elevators, escalators, and...


  • Zaragoza, Zaragoza, España Advanced Accelerator Applications (Italy) - S... A tiempo completo

    Cybersecurity Solutions Architect (Global Drug Development Team)Job ID: 379140BRWe are seeking a Cybersecurity Solutions Expert to support the development of new systems and platforms for drug development pipelines, clinical trials, and proof-of-concept initiatives in our global drug development team.Our global drug development team collaborates across...


  • Zaragoza, Zaragoza, España Ferrovial Agroman A tiempo completo

    Cintra OverviewCintra is the highways business unit of Ferrovial, a leading global infrastructure operator committed to developing sustainable solutions. With over 55 years of experience in innovative highway development across four continents, Cintra has established itself as a premier private-sector transportation infrastructure company.Our...


  • Zaragoza, Zaragoza, España Atlas Copco A tiempo completo

    Job DescriptionWe are seeking an experienced Customer Support Expert to join our team in Zaragoza, Spain. As a key member of our global technical support organization, you will be responsible for providing exceptional technical support to our customer centers.About the RoleThis is a challenging and rewarding opportunity to lead a team of technical support...


  • Zaragoza, Zaragoza, España Healthcare Businesswomen'S Association A tiempo completo

    Job OverviewSandoz, a global leader in sustainable generic and biosimilar medicines, is seeking an experienced Digital Transformation Expert to lead the Technology strategy for its International Region. As a key member of the Sandoz Region International (SIR) team, you will oversee the overall relationship with the region and technology, ensuring seamless...

  • Cybersecurity Expert

    hace 1 semana


    Zaragoza, Zaragoza, España Course A tiempo completo

    About Us Deloitte is a global consulting firm that aims to make an impact on society and our clients. Our professionals work across disciplines and borders to develop and lead global initiatives, delivering strategic programs and services that unite our organization.Job Title: Cybersecurity Expert - Threat ProfilerJob DescriptionYou will be part of a team...


  • Zaragoza, Zaragoza, España Wise Security Global A tiempo completo

    We are seeking an experienced Cybersecurity Sales Expert to join our Business Development team in Madrid. As a key member of our sales crew, you will be responsible for generating demand by assisting clients to identify and qualify current needs and effectively articulate how Wise can add value through its services and solutions offered.Become part of our...

  • Full Stack Expert

    hace 1 mes


    Zaragoza, Zaragoza, España Wise Security Global A tiempo completo

    Company OverviewWe are a dynamic and innovative company, Wise Security Global, seeking a talented Full Stack Senior Developer to join our Blockchain business unit.Compensation PackageThe estimated salary for this position is between €65,000 - €95,000 per year, including flexible compensation plans, meal cards, transportation cards, medical insurance, and...


  • Zaragoza, Zaragoza, España Foreo A tiempo completo

    ¿Quieres formar parte de un gran equipo en crecimiento y ofrecer una experiencia excepcional a los clientes? Foreo, líder mundial en tecnología de belleza, busca un/a Dependiente/a - Reclutador de Expertos en Belleza para incorporarse a uno de nuestros puntos de venta en Pozuelo de Alarcón (Madrid).¿Por qué elegir FOREO?Cultura empresarial única e...


  • Zaragoza, Zaragoza, España Hitachi Vantara Corporation A tiempo completo

    Hitachi Rail is looking for a highly motivated Digital Transformation Expert who thrives in a fast-paced environment. This role is based in Madrid, Spain. With operations in every corner of the world, our work pushes the boundaries of digital transformation and technology. Our company prides itself on its multi-cultural strength and sustainable ways of...

  • Director Comercial Global

    hace 2 semanas


    Zaragoza, Zaragoza, España Compañía Portuguesa Alemana A tiempo completo

    Resumen del PuestoNuestra compañía busca un Líder Reclutador Equipo En Network Internacional con capacidad para desarrollar su propio equipo comercial y gestionar la red desde casa.Tu DesafíoEn Compañía Portuguesa Alemana, nos enfocamos en ayudarte a encontrar tu camino profesional. Buscamos personas apasionadas por el desarrollo de equipos comerciales...


  • Zaragoza, Zaragoza, España Yolk Recruitment Ltd A tiempo completo

    At Yolk Recruitment Ltd, we are partnering with a renowned travel company to find an experienced Global IT ERP SAP SuccessFactors Consultant. This role is centered around managing the implementation and support of SAP SuccessFactors across the company's global operations.Key ResponsibilitiesProvide expert configuration and support for key SAP SuccessFactors...


  • Zaragoza, Zaragoza, España Jti A tiempo completo

    Job Description:The Product Expert Manager will secure in-house knowledge and governance of Digital Activities/Ploom Activities related to the commercial engine and the main business drivers. This role will oversee the DES roadmap evolution to ensure alignment with the Ploom Global business strategy. Additionally, the Product Expert Manager will ensure that...

  • SAP Logistics Consultant

    hace 1 semana


    Zaragoza, Zaragoza, España Sulzer Ltd A tiempo completo

    About Sulzer LtdSulzer is a global leader in fluid engineering and chemical processing applications. We specialize in energy-efficient pumping, agitation, mixing, separation, purification, crystallization, and polymerization technologies for fluids of all types.Our solutions enable carbon emission reductions, development of polymers from biological sources,...


  • Zaragoza, Zaragoza, España Lhh Recruitment Solutions A tiempo completo

    Ficha del EmpleadoNuestro cliente, una empresa líder en el sector de la ingeniería y fabricación de maquinaria industrial, busca a un Especialista en Coordinación de Proyectos Globales. Este profesional estará encargado de coordinar proyectos internacionales, asegurando su éxito y sostenibilidad. Si eres un experto en gestión de proyectos y buscas un...


  • Zaragoza, Zaragoza, España Tetra Pak A tiempo completo

    About Tetra PakTetra Pak is a leading food processing and packaging company committed to making food safe and available everywhere. With a strong focus on sustainability, innovation, and customer satisfaction, we strive to protect what's good - for food, people, and the planet.Job SummaryWe are seeking a highly skilled Logistics Analyst to join our team in...


  • Zaragoza, Zaragoza, España Bredlak A tiempo completo

    Bredlak is a leading international trading company specializing in recyclable and non-prime materials. Our headquarters are located in Lille, France, with offices in Spain and India. We are dedicated to buying and selling plastics, metal scrap, and non-prime steel products worldwide, serving markets across Europe, Asia, Africa, and the Americas. As an agile...