Drug Safety Officer
Location
Spain, community of madrid
Job Type
Full-time
Category
Other-General
Posted
June 08, 2026
¡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 Asp...