Local Person for Pharmacovigilance - modena - Hlx Life Sciences

Descrizione

Local Pharmacovigilance Responsible Person

Location: Italy

Employment 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 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