Local Pharmacovigilance Responsible PersonLocation: 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 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 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