Descrizione:
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 solving
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.
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 smart working al mese.
Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza.
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.)