Pharmacovigilance Safety officer

multinazionale italiana leader nella produzione di API e Prodotti Finiti, è alla ricerca di una figura motivata e orientata alla qualità da inserire nel team di Pharmacovigilance come Drug Safety Officer. La risorsa sarà coinvolta in attività chiave legate alla gestione della sicurezza dei farmaci e alla compliance regolatoria, collaborando attivamente con team multidisciplinari in un contesto altamente regolato e internazionale. almeno 1 anno di esperienza in Pharmacovigilance laurea in discipline scientifiche (preferibilmente Farmacia o CTF) La posizione rappresenta un'interessante opportunità di crescita professionale in un ambiente dinamico e strutturato, con coinvolgimento in attività di case management, screening della letteratura, signal detection, reportistica aggregata e processi di qualità. La posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di smart working al mese. Role: Drug Safety Officer Reports to: Drug Safety Manager 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. 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). 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. 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 Ability to work independently, with appropriate levels of supervision for a junior role Effective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department 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) 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.)