This website uses cookies to improve your user experience. Continuing to browse this website will be seen as your consent to us for placing cookies on your computer and using those cookies.
More information can be found in the Cookies-section of our Privacy Policy.
OK

EU QPPV

Hainaut, Belgium

Benson & Winch is looking for a EU QPPV to join a pharmaceutical company specialized in the production and distribution of niche hospital products.

Your responsibilities

The EU QPPV will perform the following activities on behalf of the Marketing Authorization Holder:

-Oversight of the PV system.
-Acts as a main PV contact point for the local and European regulatory authorities
-Ensure that the Marketing Authorization Holder has appropriate PV system in place. This includes the entire PV processes including ICSR collection and reporting, PSMF -maintenance, production of PSURs, CCDS, RMPs and signal detection reports and compliance.
-Oversees functioning of PV systems in all relevant aspects including its quality systems including SOPs, Training, Contractual arrangements, Database operations, Compliance data regarding quality, Audit/inspection reports
-Ensuring that all PV processes conducted are in accordance with pertinent regulations
-Maintains an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products
-Ensures that the signal management process is in place in order to identify possible safety signals on Marketing Authorization Holder products

Your profile

You are holding a diploma of Doctor, Pharmacist, Veterinarian or a master degree in Sciences
You will need to have experience in Pharmacovigilance at a senior level and also have experience in a QPPV role
You master local and European legislations of pharmacovigilance (Good pharmacovigilance practices).
You are organized, pro-active, flexible, stress resistant and are able to handle effectively different projects at the same time.
You speak French and English (Dutch is a plus) and have good computer skills.
You master PcVmanager

This description matches your profile and expectations?

Jobs Overview