LOCAL QPPV - FREELANCE 0.2 FTE - HOME BASED (only in Italy)

About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The local QPPV acts as the local pharmacovigilance representative in Italy and serve as the primary liaison between the Italian affiliate, Agenzia Italiana del Farmaco (AIFA), and the EU QPPV, ensuring the implementation and compliance of local pharmacovigilance requirements. Ultimate responsibility for the pharmacovigilance system remains with the EU QPPV.

Key Responsibilities

• Regulatory Support and Authority Interactions
• Act as the local point of contact for pharmacovigilance matters with AIFA.
• Facilitate communication between the company, the EU QPPV, and Italian regulatory authorities.
• Support the preparation, coordination,



and submission of responses to pharmacovigilance-related regulatory requests.
Safety Information Management
• Support the collection, follow-up, and escalation of adverse events and other safety information originating in Italy.
• Ensure that all local safety information is forwarded to the global pharmacovigilance system within the required timelines.
• Collaborate in case follow-up activities and obtaining additional safety information when required. [en.direnzo.biz]
Pharmacovigilance System Compliance
• Support the implementation and maintenance of the Pharmacovigilance System and applicable local procedures.
• Ensure that local pharmacovigilance activities are performed in accordance with Good Pharmacovigilance Practices (GVP), corporate procedures, and national requirements.
• Maintain awareness of Italian pharmacovigilance regulations and communicate relevant regulatory updates to the organization.

Qualifications

· Bachelor’s Degree, preferabl

📌 Local QPPV (Roma)
🏢 Tfs Healthscience
📍 Roma