Drug Safety Officer – Pharmacovigilance

About the role

ACS DOBFAR S.p.A., a leading Italian API and finished‑product manufacturer, is looking for a motivated Drug Safety Officer to join its Pharmacovigilance team. The role focuses on ensuring drug safety and regulatory compliance in a highly regulated, international environment.

Key responsibilities

• Screen spontaneous adverse event reports in EudraVigilance.
• Conduct literature searches using PubMed, MLM and local scientific journals.
• Review and quality‑check results from EudraVigilance and literature searches.
• Enter and manage AE/ADR data in the pharmacovigilance database.
• Identify, verify and resolve duplicate cases and follow‑up information.
• Support new referral procedures and PSUSA activities.
• Assist in preparing product‑related messages for the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
• Help Drug Safety Specialists compile aggregate reports (PADERs, PSURs) and support signal detection.
• Maintain electronic and paper archives of pharmacovigilance documentation.
• Contribute to quality‑system activities such as deviations, CAPAs, audits and inspections.

Required profile

• At least 1 year of experience in pharmacovigilance.
• Degree in a scientific discipline (Pharmacy or related).
• Strong organizational skills, attention to detail and problem‑solving attitude.

Required skills

• Good knowledge of GVP regulations and Italian/European PV guidelines.
• Familiarity with the EudraVigilance system.
• Proficiency with the MedDRA dictionary.
• Experience conducting literature searches (PubMed, MLM).

What we offer

• Full‑time permanent position based in Agrate Brianza.
• Hybrid work model with up to 10 days of remote work per month.
• Dynamic, structured environment with opportunities for professional growth.