Pharmacovigilance & Patient Safety.

hace 1 mes


Madrid, España Michael Page A tiempo completo
¿Dónde vas a trabajar?

This company is a large global player in the life science industry. With a workforce exceeding 2000 employees, the company is constantly striving to improve patient outcomes and quality of life by developing innovative pharmaceutical products. The firm is based in Madrid and operates in numerous locations worldwide.

¿Qué harás en tu nuevo puesto?

- Perform medical assessments of adverse event reports and MedDRA adverse event coding.

- Prepare and/or review of aggregated reports, such as Periodic Safety update Reports, Development Safety Update Reports, Addendums to the Clinical Overviews, Risk Management Plans, among others.

- Provide input to benefit risk-assessments and Clinical Expert Statement as applicable.

- Review documents related to clinical trials and post-authorization safety studies where the R&D departments.

- Assist with the medical review and narrative writing in completion of clinical study reports and clinical documents supporting a marketing authorization application.

- Give medical support to the manufacturing sites when reassessment of the benefit-risk balance of manufactured products is required.

- Provide answers to medical inquiries and prepare benefit risk assessments reports if needed.

- Provision of a medical expert opinion in the medical monitoring, signal detection and risk management activities.

- Participation in the decision-making performed by the Signal Management Team and Signal Detection Committee.

- Review global scientific literature, social media, and other sources of safety information with the purpose of continuously monitoring the benefit-risk balance product portfolio and development candidates.

- Provide 24/7 medical assistance to the Qualified Person of Pharmacovigilance (QPPV).

- Collaborate in the establishment of a Quality Pharmacovigilance System for the Medical Safety and Business Support Department.

- Provide medical safety evaluations for the creation and maintenance of product information documents (e.g. Reference Safety Information/Core datasheets/SmPC).

- Collaborate with other departments and business units, affiliates, and business partners.

- Collaborate with external key stakeholders as applicable.

¿A quién buscamos (H/M/D)?

- Education: Degree in Medicine. A full and partly completed postgraduate program with a curriculum in pharmacovigilance would be advantageous

- Experience (years/area): Hospital medical experience in patient care (e.g. medical residency of internal medicine, clinical pharmacology, or similar) and preferentially some years of experience in a PV Department of a medium-large pharmaceutical company, a CRO or in a hospital setting managing the system of adverse event reporting.

- Specific Knowledge: Knowledge of pharmacovigilance vocabulary and current European PV Legislation and Good pharmacovigilance practices (GVP).

- Languages: Fluent in Spanish and English. Knowledge of other languages will be an asset

- Travels: Willing to travel, as required.

- Personal skills: Communication, analytical skills, sense of responsibility, sociable, flexibility.

¿Cuáles son tus beneficios?

- A vibrant, inclusive culture that values employee well-being and development.

- The chance to work in a global life science company with a strong commitment to improving patient lives.

- Generous holiday leave and flexible work arrangements.

If you are an experienced professional in the life science industry with a passion for drug safety, we encourage you to apply for this exciting opportunity in Madrid.

  • Madrid, España Michael Page A tiempo completo

    ¿Dónde vas a trabajar? This company is a large global player in the life science industry. With a workforce exceeding 2000 employees, the company is constantly striving to improve patient outcomes and quality of life by developing innovative pharmaceutical products. The firm is based in Madrid and operates in numerous locations worldwide. ¿Qué harás en...

  • Drug Safety Physician

    hace 4 semanas


    Madrid, España AL Solutions A tiempo completo

    Taylor Young is Exclusively partnered with a Global Pharmaceutical company that wants a Drug Safety Physician located in Spain to join their successful, passionate team!My client has very strong core values which results in a great work environment and very happy staff.This role is a Hybrid position for you to have the best of both worlds. This is a unique...


  • Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid. **What you will do**: - Translation of source documents in local language. - Reconciliation activities. - Literature search and other related activities. - Local archive management, ensuring documents generated in the daily...


  • Madrid, España Teva Pharmaceuticals A tiempo completo

    The opportunityAs a Director, Global Pharmacovigilance - Neurology Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle.  You will lead activities necessary to determine the safety profile and the characterization,...


  • Madrid, España Novartis A tiempo completo

    Director Process Governance Compliance & Risk is accountable for establishing, maintaining and optimizing the process governance, assessing pharmacovigilance system regulatory risks and driving global pharmacovigilance process enhancements to support key technology and business transformation efforts in close collaboration with Head Patient Safety Operations...


  • Madrid, Madrid, España J&J Family of Companies A tiempo completo

    Internship Pharmacovigilance WDescriptionJohnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments...


  • Madrid, España PrimeVigilance A tiempo completo

    **Company Description** We are PrimeVigilance (part of Ergomed Group), 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...


  • Madrid, España BAXTER A tiempo completo

    **Vantive: A New Company Built On Our Legacy** Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...


  • Madrid, España Baxter A tiempo completo

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...


  • Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and...

  • Health & Safety Intern

    hace 6 horas


    Madrid, España OFFICE Internship AWWG A tiempo completo

    We are very happy to announce the launch of our International Internship & Graduate program. A new initiative that aims to bring to AWWG a great dose of talent, innovation, diversity, vitality and passion!AWWG is a leading fashion company with brands such as Pepe Jeans, Hackett London and Façonnable. Our Programs are a chance to start learning and...

  • Senior Health

    hace 4 días


    Madrid, España Edwards Lifesciences A tiempo completo

    Innovation 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...


  • Madrid, España PrimeVigilance A tiempo completo

    Job DescriptionThe PV Associate should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) This is an opportunity for new graduates to start and develop their career within drug safety. The PV Associate will be working as part of a project team,...

  • Senior Health

    hace 6 días


    Madrid, España Edwards Lifesciences A tiempo completo

    Innovation 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...

  • Senior Health

    hace 6 días


    Madrid, España Edwards Lifesciences A tiempo completo

    Innovation 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...


  • Madrid, Madrid, España Blu Selection A tiempo completo

    As the main point of contact throughout the breast aesthetic journey, the Patient Care plays a crucial role in assisting consumers. Your role in this position will be to proactively engage with customers prior to their surgery. This can be accomplished by supplying them with essential information about the company's offerings through various communication...

  • Clinical Project Manager

    hace 4 semanas


    Madrid, España IQVIA A tiempo completo

    Project Managers are an integral part of PCS study delivery, liaising with patient science consultants to bring patient experience data forward for the evaluation of the safety and efficacy of new treatments. The Project Manager is an essential member of the core project team responsible for project delivery our studies to meet contractual requirements in...


  • Madrid, España IQVIA A tiempo completo

    IQVIA Safety Operations team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ‘safety hubs’ in Ireland, Poland, Austria, Portugal, Slovakia, Spain,...

  • Pv Associate

    hace 4 días


    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...


  • Madrid, España Novasyte A tiempo completo

    Project Managers are an integral part of PCS study delivery, liaising with patient science consultants to bring patient experience data forward for the evaluation of the safety and efficacy of new treatments. The Project Manager is an essential member of the core project team responsible for project delivery our studies to meet contractual requirements in...