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Drug Safety Officer

Company

ASPHALION

Location

Spain, community of madrid

Type

Full-time

¡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...

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