Drug Safety Officer
Pubblicato il 05-09-2026 - ACS DOBFAR in Agrate Brianza
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 deta