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, preferably in life sci

📌 Local QPPV (Lazio)
🏢 Tfs Healthscience
📍 Lazio