Job Description
About the role
We are seeking a Drug Safety Officer to support Asphalion’s pharmacovigilance activities.
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 (EUQPP).
- 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 expert medical advice and support Medical Information...
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