Local Pharmacovigilance Responsible PersonLocation: ItalyEmployment Type: Part-Time, Contract
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 tempo parziale role requiring approximately ***** 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 AIFAEnsure full compliance of the local PV system in line with Italian and EU legislationManage LPPV notification and ongoing regulatory obligationsCollect, review, report and follow up on ICSRs and other safety informationMonitor the local safety profile of products and escalate emerging risksMaintain and review local PSMF sections or annexes as applicableSupport inspections and audits, ensuring inspection readinessImplement regulatory updates and ensure ongoing complianceProvide PV training to relevant stakeholdersEnsure business continuity and appropriate escalation of urgent safety issuesBeing available 24/7 in line with local PV regulatory requirements and project needs.
Requirements:Experience within Pharmacovigilance in ItalyStrong knowledge of Italian and EU PV legislationDegree in Life Sciences, Pharmacy, Medicine or related healthcare disciplineFluency in Italian and English