Corporate PV Governance Expert

Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D;, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, Health&Wellness; Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.

Job Description

We are recruiting a

Corporate Pharmacovigilance Governance Expert – Temporary contract

The candidate will support the management and oversight of the Corporate PV Governance Unit activities.

Main responsibilities:
- Support the management of the Affiliates and their oversight related to the Pharmacovigilance System, ensuring that contract and Pharmacovigilance Agreement (PVA) related to medicinal products are in place with Affiliates, and verify compliance monitoring;
- Support the management, release and reporting of the Pharmacovigilance System Master Files (PSMFs)



for human and veterinary products, and any Pharmacovigilance Sub-System Master File (PSSF);
- Support the preparation of materials and delivery of training on pharmacovigilance at HQ and Affiliates level;
- Support the management of GVP Audit and Inspection and ensure Deviation & CAPA management;
- Contribute to Key Performance Indicator (KPI) Management at Corporate Level for the Pharmacovigilance System of human and veterinary products;
- Contribute to write and review the Corporate SOPs/Wis and Quality Management Review (QMR) for the Pharmacovigilance System;
- Contribute to ensure that sponsored digital assets comply with pharmacovigilance requirements;
- Contribute to the management of GVP archives for the pharmacovigilance system;
- Contribute to Regulatory Intelligence for EU Territories for the Pharmacovigilance System.

Requirements:
- Degree in Pharmacy, Pharmaceutical Chemistry, Biology, Bi