For our Global Clinical Safety & Pharmacovigilance department we are currently recruiting a :
Director, Deputy Qualified Person for Pharmacovigilance
Based in Brussels or another EU-country (except United Kingdom)
Reporting into the Associate Vice President / European Qualified Person Risk Management & Pharmacovigilance (QPPV) you will represent MSD as a Deputy to the EU Qualified Person for Pharmacovigilance.
This position is required under current European Union (EU) Regulations, Directives and Guidance. You will, in back-up to the EU QPPV, carry responsibility for ensuring compliance with all EU regulatory requirements relating to PV for products approved in the EU.
You will have broad oversight of all aspects of the global PV system which are applicable in the EU and as such you will interact closely with the EU QPPV, Regulatory Affairs Europe, European Economic Area (EEA) subsidiary employees and EU regulatory authorities concerning all aspects of PV.
You will interact closely with Global Pharmacovigilance and MRL Quality Assurance and you will have a particular focus on the EEA Regional PV Head and country-
based PV staff to ensure oversight of the PV system at a country level in the EU. Finally you will interact with all relevant corporate functions and internal groups that impact PV.
Main areas of responsibility :
Establishing and maintaining good relations and effective communications with the EMA and Member State Authorities to ensure timely communication to the company of any potential safety issue and for clarification of requirements relating to PV.
Representing MSD in relevant national and international expert groups, key to PV.
Questions and further information regarding the position can be addressed to Guy Demol, Associate Vice President / European Qualified Person Risk Management & Pharmacovigilance (QPPV), based in Brussels, by phone : 00 32 2 7767014.
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter.
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