Safety Advisor I

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.

La descrizione completa del lavoro illustra tutte le competenze, l'esperienza pregressa e le qualifiche che i candidati dovrebbero possedere.
almeno 1 anno di esperienza in Pharmacovigilance
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.

Role: Drug Safety Officer
Reports to: Drug Safety Manager

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.
# 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).
# 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. 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

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.)