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