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.
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
Bachelors 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.
Employment Type : Full Time
Experience: years
Vacancy: 1
Local QPPV FREELANCE • Roma, Italy
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