Local QPPV - FREELANCE

TFS HealthScience; Roma; In loco; EUR 70.000 - 100.000; Part-time

Descrizione del lavoro

TFS HealthScience is seeking a Local QPPV (0.2 FTE freelance) based in Italy to serve as the local pharmacovigilance representative. You will liaise between the Italian affiliate, AIFA, and the EU QPPV, ensuring local PV requirements are implemented and compliant while maintaining overall PV system integrity.

The role involves regulatory interactions, safety information management, and PV system compliance, with responsibilities spanning AE collection, surveillance, and reporting within Italy.

Competenze

• 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.

Mansioni

• 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.
• 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.
• 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.

Conoscenze

Regulatory knowledge

Pharmacovigilance experience

Communication skills

GCP/ICH knowledge

Independent work

Formazione

Bachelor’s Degree (life science or nursing)

Descrizione del lavoro

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.