Local Person for Pharmacovigilance - arezzo - Hlx Life Sciences

    Hlx Life Sciences
    Hlx Life Sciences arezzo

    5 giorni fa

    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
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