Drug Safety Officer

Location: 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 Eudra Vigilance.

Performs literature searches using Pub Med, MLM, and local scientific journals.

Reviews and quality checks results from Eudra Vigilance 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 Eudra Vigilance 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 Eudra Vigilance 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.)

#J-18808-Ljbffr