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 Effective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department Ability to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively IT Skills Required Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) Proficiency in Adobe Acrobat Language Skills Required Italian: Native or professional proficiency both written and spoken (C1) English: Professional proficiency both written and spoken (B2) Education Degree in scientific field, preferably Chemistry and Pharmaceutical Technology Previous experience in the role or in a similar position within the sector At least 1 year of experience in the field of Pharmacovigilance.

Certifications and Authorizations Degree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.)

📌 EHS Advisor (Pharma) (Agrate Brianza)
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📍 Agrate Brianza