Safety Expert

Resumen

Localización

Area

Tipo de contrato

Fecha de publicación

17-10-2025

Descripción de la oferta

Drug Safety Professional We are seeking a skilled and detail-oriented Drug Safety Officer to join our team. As a key member of our pharmacovigilance department, you will be responsible for ensuring the safety of drugs by monitoring and analyzing adverse event reports. Literature Assessments: Perform weekly global/local literature assessments to identify potential safety issues associated with our products. Key Responsibilities: Efficiently manage Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities. Manage cases through the Pharmacovigilance Database and report accurately to European authorities via EudraVigilance. Translate relevant pharmacovigilance information into English and liaise with Spanish Regulatory Authorities. Provide support to local and EU Qualified Persons for Pharmacovigilance (EUQPPv). Stay informed about updates in global and local pharmacovigilance regulations. Oversee the maintenance of the PSMF and Asphalion's Pharmacovigilance System (SOPs). Prepare and review PSURs, RMPs, DSURs, and ACOs with attention to detail. Offer expert medical advice and support Medical Information projects. Draft and review Pharmacovigilance agreements and provide strategic insights. Prepare and conduct internal Pharmacovigilance training sessions. Requirements: +2 years experience in Pharmacovigilance departments. Fluent in English (C1) & Spanish Advanced IT level – (MS Office) Academic Degree in Life Science and Pharmacovigilance. Proactive, good communication, accurate, detail orientated, teamwork Benefits: Permanent contract. Flexible working schedule - Friday until 15:30h. Home office & Hybrid or Remote Model (You can be located anywhere in Spain). Wide variety of projects, new challenges and experiences. Training and personal development program. English lessons. A professional, inclusive and high-performance work environment to develop your skills and grow your career. About Us: We prioritize the physical, psychological and emotional well-being of our employees. We have a dynamic working environment with employees from more than 15 nationalities.

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