Mission Safety Member – Spain

buscojobs España; País Vasco; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Une entreprise dynamique recherche un Spécialiste en Pharmacovigilance pour rejoindre son équipe. Ce rôle clé implique la gestion de la conformité et de la qualité dans un environnement stimulant. Si vous parlez espagnol et avez une expérience en pharmacovigilance, cette opportunité est faite pour vous.

Formación

• Expérience en pharmacovigilance requise.
• Capacité à travailler en équipe et à gérer des processus de qualité.
• Compétences en audit et préparation d'inspections.

Responsabilidades

• Assurer la conformité avec les processus de pharmacovigilance.
• Gérer le système de gestion de la qualité.
• Collaborer avec les équipes de sécurité des patients.

Conocimientos

Gestion de la qualité

Collaboration

Conformité réglementaire

Descripción del empleo

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Job Title :

Pharmacovigilance Specialist (Spanish speaker)

Location :

Spain or any EU country

Type :

Remote, fixed term contract

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in post-authorization safety monitoring, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

The role involves ensuring compliance with pharmacovigilance processes, collaborating closely with LSOs and Patient Safety teams to meet local and global obligations. Key responsibilities include managing the quality management system, overseeing SOPs and documents, and performing gap analysis to align with global standards. The role also involves supporting audit and inspection readiness, overseeing local deliverables, and contributing to various Int PV activities and projects. The team plays a vital role in maintaining high-quality safety and regulatory compliance in the pharmaceutical industry.

Main Responsibilities :

• Perform the periodic QC process for the cases managed by SP-Int PV.
• Work in close collaboration with the LSOs and relevant Patient Safety colleagues to ensure that local obligations are managed and compliance to local authorities is maintained.
• Provide input into global / local processes to secure compliance.
• Maintain quality management system related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs), and documents (e.g., forms, templates) to describe local processes and requirements, and perform regular gap analysis as needed to ensure alignment with global SOPs.
• Maintain oversight of local deliverables delegated to service providers.
• Support audit and inspection readiness activities.
• Support Int PV activities or projects as needed.

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