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 science or nursing; or
equivalent · 5+ years of relevant experience · Able to work in a
fast-paced environment with changing priorities · Understand the
medical terminology and science associated with the assigned drugs
and therapeutic areas · Understanding of the Good Clinical Practice
regulations, ICH guidelines, Pharmacovigilance legislation and
internal SOPs · Ability to work independently as well as in a team
matrix organization with little or no supervision · Excellent
written and verbal communication skills · Demonstrate proficiency
using typical word processing; spreadsheets desirable; and
presentation software a plus What We Offer We provide opportunities
for personal and professional growth in a rewarding environment.
You will join a team that values collaboration, quality, and making
a difference in the lives of patients. Our core values of Trust,
Quality, Passion, Flexibility, and Sustainability guide our
decisions and shape our culture. By aligning on these values, we
foster collaboration, innovation, and a shared commitment to
excellence. Together, we make a difference. A Bit More About Us Our
journey began over 30 years ago in Sweden, in the city of Lund. As
a full-service global CRO, we build solution-driven teams working
toward a healthier future. Bringing together over 600
professionals, TFS delivers tailored clinical research services in
more than 50 countries, offering flexible clinical development and
strategic resourcing solutions across key therapeutic areas
including Dermatology, Neuroscience, Oncology, and
Ophthalmology.

📌 Local QPPV - FREELANCE (Lazio)
🏢 Tfs Healthscience
📍 Lazio