Location
madrid
Job Type
Full-time
Posted
June 19, 2026
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 general and local pharmacovigilance regulations.
- Oversee the maintenance of the PSMF and Asphalion’s Pharmacovigilance System (SOPs). <...