Role: Drug Safety Officer
Reports to: Drug Safety Manager
Main responsibilities
Ensures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures.
Conducts screening of spontaneous adverse event reports in EudraVigilance.
Performs literature searches using PubMed, MLM, and local scientific journals.
Reviews and quality checks results from EudraVigilance and literature searches.
Manages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database.
Identifies, verifies, and confirms potential follow-up information and duplicate cases.
Performs checks related to new referral procedures and PSUSA activities.
Supports the preparation of product-related messages within the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
Assists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs).
Supports Signal Detection Management activities.
Manages electronic and paper archiving of pharmacovigilance documentation and reports.




Contributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections.
Ensures compliance with data integrity principles across all pharmacovigilance activities.
Technical/Regulatory Skills Required
Good knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and relevant Italian and European guidelines
Familiarity with the EudraVigilance system, with the ability to support the entry and management of safety reports under supervision
Good knowledge of the MedDRA dictionary and its use for coding adverse event data
Understanding of fundamental pharmacovigilance principles and key international regulatory requirements
Soft Skills Required
Problem‐solving skills with a proactive and solution‐oriented approach
Ability to work independently, with appropriate levels of supervision for a junior role
Strong attention to detail and accuracy in performing tasks
Effectiv

📌 Drug Safety Officer (Italia)
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📍 Italia