Pharmacovigilance & Patient Safety.

Madrid Permanente Remoto / híbrido

Actualizado el 12/04/2024

  • Degree in Medicine.
  • Experience in a PV Department of a medium-large pharmaceutical company.

¿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.

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Paula Martínez
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Resumen de empleo

Sub Sector
Healthcare / Pharmaceutical
Tipo de Contracto
Nombre del consultor
Paula Martínez
Número de referencia
Modalidad de trabajo
Remoto / híbrido

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