ACS DOBFAR S.p.A. 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.Il profilo ideale possiede:- almeno 1 anno di esperienza in Pharmacovigilance- buona conoscenza delle normative GVP, EudraVigilance e MedDRA- laurea in discipline scientifiche (preferibilmente Farmacia o CTF)- ottime capacità organizzative, attenzione al dettaglio e attitudine al problem solvingLa 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.Se sei interessato/a o conosci qualcuno in linea con questa opportunità, inviaci la tua candidatura tramite questo annuncio o sul sito di ACS nella pagina "careers".La posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di lavoro da remoto al mese.Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza.Role: Drug Safety OfficerReports to:



Drug Safety ManagerMain 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 requirementsSoft 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 effectivelyIT Skills Required:- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)- Proficiency in Adobe AcrobatLanguage 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 TechnologyPrevious 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.)

📌 Drug Safety Officer (Como)
🏢 ACS DOBFAR
📍 Como