Drug Safety Officer
Pubblicato il 05-08-2026 - ACS DOBFAR in Bardi
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 Drug Safety Officer.
p 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 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 /pp La posizione rappresenta un'interessante possibilità 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.
/pp 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".
/pp La posizione è full-time presso gli uffici di Agrate Brianza con possibilità di 10 giorni di smart working al mese.
/pp Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza.
/pp Role: Drug Safety Officer /pp Reports to: Drug Safety Manager /pp Main responsibilities: /pulli 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.
/li /ulp Technical/Regulatory Skills Required: /pulli 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 /ulp Soft Skills Required: /pulli 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 /ulp IT Skills Required: /pulli Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) /lili Proficiency in Adobe Acrobat /li /ulp Language Skills Required: /pulli Italian: Native or professional proficiency both written and spoken (C1) /lili English: Professional proficiency both written and spoken (B2) /li /ulp Education: /pulli Degree in scientific field, preferably Chemistry and Pharmaceutical Technology /li /ulp Previous experience in the role or in a similar position within the sector: /pp At least 1 year of experience in the field of Pharmacovigilance.
/pp Certifications and Authorizations: /pp Degree, preferably in a scientific field (Pharmaceutical Chemistry and Technology, Chemistry, Biotechnology, Biology, etc.) /p /p