Job Description
¡Be part of the future of drug safety at Asphalion! We’re looking for a Drug Safety 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 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 e...