Corporate PV Governance Expert

Fidia Pharma; Abano Terme; In loco; EUR 30.700 - 38.300; Tempo pieno

Vantaggi offerti da questo lavoro

Collective Bonus

Company Welfare

Descrizione del lavoro

Fidia Farmaceutici is seeking a Corporate Pharmacovigilance Governance Expert for a one-year fixed-term contract. The role oversees PV governance activities, ensures contracts and PV agreements with Affiliates, and supports PSMF management for human and veterinary products.

Responsibilities include preparing PV materials, training, audits, KPI reporting, SOP improvements, and regulatory intelligence within the corporate PV framework. English fluency and MS Office proficiency are required.

Competenze

• Degree in Pharmacy, Pharmaceutical Chemistry, Biology or related field.
• 1 year of experience in a pharmacovigilance role.
• Knowledge of EU GVP and related regulations is required.
• Experience with PSMF management is preferable.

Mansioni

• Support management of Affiliates and oversight related to the Pharmacovigilance System and PVAs.
• Assist in management, release and reporting of PSMFs and PSMSF for human and veterinary products.
• Contribute to training materials on pharmacovigilance for HQ and Affiliates.
• Support GVP audits, inspections, deviations and CAPA management.
• Contribute to KPI management for the PV system at corporate level.
• Draft and review Corporate SOPs/Wis and Quality Management Review for PV.
• Ensure sponsored digital assets comply with PV requirements.
• Assist in PV system archives management.
• Support regulatory intelligence for EU territories related to PV.

Conoscenze

English fluency

Pharmacovigilance experience

GVP knowledge

Planning & organization

Analytical skills

Problem solving

Teamwork

MS Office

Formazione

Degree in Pharmacy / Pharmaceutical Chemistry / Biology / Biotechnologies

Master’s degree in Pharmacovigilance (plus)

Strumenti

Microsoft Office

Descrizione del lavoro

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, Biotechnologies or other scientific related fields. A second level master’s degree in Pharmacovigilance is considered a plus;
• At least 1 year of experience in a similar role within Pharmacovigilance;
• A good knowledge of EU GVP is required, and familiarity with international pharmacovigilance regulations would be an advantage;
• Previous involvement with the management of the PSMF is preferred;
• Proficiency in the use of Microsoft Office Suite (i.e. Excel, Word, Outlook and Teams);
• Fluency in written and spoken English;
• Planning, organizational and analytical skills are required, as well as problem-solving and teamwork skills.

Our offer:

• One-year fixed term contract;
• Salary between € 30.700 and € 38.300;
• Collective Bonus and company Welfare.

In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.

Fidia Farmaceutici promotes parity and inclusion in all its actions.

All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.

All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.