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.

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.

Per questa selezione verranno considerati solo candidati/e domiciliati nelle vicinanze di Agrate Brianza.

Role: Drug Safety Officer Reports to: Drug Safety Manager

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. # 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.

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

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