Be part of the future of drug safety at Asphalion We’re looking for a Drug Safety Senior Officer ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we’d love to have you on our team Main responsibilities: * Perform weekly global/local literature assessments. * Efficiently manage post-marketing activities including 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 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. If you’re passionate about ensuring drug safety and eager to grow professionally, join us at Asphalion and be part of a team at the forefront of pharmacovigilance innovation Requirements: * +4 years experience in Pharmacovigilance departments, with strong exposure to post-marketing activities. * Advanced IT level – (MS Office) * Academic Degree in Life Science or Pharmacovigilance. * Proactive, good communication, accurate, detail orientated, teamwork Why working at Asphalion? Versátil working schedule - Friday until 15.30h. Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain) Wide variety of projects, new challenges and experiences. Training and personal development program. A professional, inclusive and hi

📌 Drug Safety Senior Officer (Madrid)
🏢 Asphalion
📍 Madrid