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 general/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.- Fluent in English & Spanish- Advanced IT level – (MS Office)- Academic Degree in Life Science or Pharmacovigilance.- Proactive, good communication, accurate, detail orientated, teamworkWhy working at Asphalion?

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