Drug Safety Senior Officer (Madrid)

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 general and local pharmacovigilance regulations.
• Oversee the maintenance of the PSMF and Asp...