Deputy QPPV

UCB - Union Chimique Belge

Braine l'Alleud or Brussels, Belgium

About the role

The Deputy EEA/UK QPPV is – in support of the QPPV - responsible for the establishment and maintenance of UCB’s pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EU.

Who you’ll work with

You will report into the Head of Pharmacovigilance & QPPV office, who is the UCB global and EEA/UK QPPV.

What you’ll do

Together with the QPPV and other Deputy QPP, act as a Pharmacovigilance contact point for the EEA/UK competent authorities and the EU Agency on a 24-hour basis and as a contact point for Pharmacovigilance inspections;
In relation to the Pharmacovigilance system, together with the QPPV, is responsible for the establishment and maintenance of the UCB Pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EEA and in the UK;
This implies that the (Deputy) QPPV has the authority to influence the performance of the company Pharmacovigilance system and its related quality system to promote, maintain and improve compliance with the legal requirements;
Member of the pharmacovigilance Quality Council to regularly receive outcomes on quality trends, performance and compliance of the pharmacovigilance system and to provide strategic direction on quality performance and improvement area;
Is informed of all Pharmacovigilance audit findings identified by PVQA and their associated CAPAs;
Has access to the UCB PSMF and is in a position of authority to ensure and verify that the information contained in the PSMF is accurate and up to date.

Interested? For this position you’ll need the following education, experience and skills:

Bachelor’s degree required, Medical Degree is strongly preferred;
Several years experience within the Pharma Industry (medical or clinical development) with the majority of the experience in pharmacovigilance;
Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities;
Expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences, as well as epidemiology and biostatistics;
In-depth knowledge of EEA/UK pharmacovigilance regulations and pharmacovigilance methods with influential skills.

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