- 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.
- 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
Local Person for Pharmacovigilance - bolzano - 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:
Requirements: