p 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 b Drug Safety Officer. /bp 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. /pp La descrizione completa del lavoro illustra tutte le competenze, l'esperienza pregressa e le qualifiche che i candidati dovrebbero possedere. brp Il profilo ideale possiede: /pp almeno 1 anno di esperienza in Pharmacovigilance /pp buona conoscenza delle normative GVP, EudraVigilance e MedDRA /pp laurea in discipline scientifiche (preferibilmente Farmacia o CTF) /pp ottime capacità organizzative, attenzione al dettaglio e attitudine al problem solving /p p 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. /p p 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". /p pb La posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di lavoro da remoto al mese. /b /p pb Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza. /b /p pu Role: Drug Safety Officer /u /ppu Reports to: Drug Safety Manager /u /p pb Main responsibilities:



/b /p olli Ensures that all activities are performed in compliance with applicable pharmacovigilance guidelines and procedures. /lili Conducts screening of spontaneous adverse event reports in EudraVigilance. /lili Performs literature searches using PubMed, MLM, and local scientific journals. /lili Reviews and quality checks results from EudraVigilance and literature searches. /lili Manages data entry of adverse event/adverse drug reaction (AE/ADR) reports in the pharmacovigilance database. /lili Identifies, verifies, and confirms potential follow-up information and duplicate cases. /lili Performs checks related to new referral procedures and PSUSA activities. /lili Supports the preparation of product-related messages within the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). /lili Assists Drug Safety Specialists in the preparation of aggregate reports (PADERs and PSURs). /lili Supports Signal Detection Management activities. /lili Manages electronic and paper archiving of pharmacovigilance documentation and reports. /lili Contributes to Quality System activities, including deviations, CAPAs, changes, audits, and inspections. /lili Ensures compliance with data integrity principles across all pharmacovigilance activities. xrdbqlu /li /ol pb Technical/Regulatory Skills Required: /b /p olli Good knowledge of pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP)



and relevant Italian and European guidelines /lili Familiarity with the EudraVigilance system, with the ability to support the entry and management of safety reports under supervision /lili Good knowledge of the MedDRA dictionary and its use for coding adverse event data /lili Understanding of fundamental pharmacovigilance principles and key international regulatory requirements /li /ol pb Soft Skills Required: /b /p olli Problem-solving skills with a proactive and solution-oriented approach /lili Ability to work independently, with appropriate levels of supervision for a junior role /lili Strong attention to detail and accuracy in performing tasks /lili Effective interpersonal and communication skills, with the ability to collaborate within the Drug Safety Unit and Regulatory Affairs department /lili Ability to manage multiple activities simultaneously while respecting deadlines and prioritizing workload effectively /li /ol pb IT Skills Required: /b /p olli Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) /lili Proficiency in Adobe Acrobat /li /ol pb Language Skills Required: /b /p olli Italian: Native or professional proficiency both written and spoken (C1) /lili English: Professional proficiency both written and spoken (B2) /li /ol pb Education: /b /p olli Degree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ol pb Previous experience in the role or in a similar position within the sector: /b /p p At least 1 year of experience in the field of Pharmacovigilance. /p pb Certifications and Authorizations: /b /p p Degree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p /p /p

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