Local person for pharmacovigilance

Local Pharmacovigilance Responsible Person Location: Italy Employment Type: Part-Time, Contract (10 - 20 Hours per month) Please note this role requires existing experience as a Local Person for Pharmacovigilance. Overview: We are supporting a Marketing Authorisation Holder with the appointment of a Local Pharmacovigilance Responsible Person in Italy. This is a key regulatory position responsible for oversight of the local PV system and acting as the primary point of contact with AIFA and other relevant authorities. This is a part-time role requiring approximately 10–20 hours per month, with mandatory 24/7 availability in line with local Pharmacovigilance regulatory requirements. Key Responsibilities:

Act as the single point of contact for Pharmacovigilance matters with AIFA Ensure full compliance of the local PV system in line with Italian and EU legislation Manage LPPV notification and ongoing regulatory obligations Collect, review, report and follow up on ICSRs and other safety information Monitor the local safety profile of products and escalate emerging risks Maintain and review local PSMF sections or annexes as applicable Support inspections and audits, ensuring inspection readiness Implement regulatory updates and ensure ongoing compliance Provide PV training to relevant stakeholders Ensure business continuity and appropriate escalation of urgent safety issues Being available 24/7 in line with local PV regulatory requirements and project needs.

Requirements:

Experience within Pharmacovigilance in Italy Strong knowledge of Italian and EU PV legislation Degree in Life Sciences, Pharmacy, Medicine or related healthcare discipline Fluency in Italian and English