Our client is a consulting company that offers expertise in a portfolio of niche services that spans the entire lifecycle of a product. They offers expertise from clinical development to marketing authorization to post-launch activities that includes: biostatistics, regulatory affairs quality, market access, medical Writing and Pharmacovigilance. They facilitate interaction with health authorities.
The Local Person for Pharmacovigilance in Belgium is responsible for the establishment and maintenance of the marketing authorisation holder’s local pharmacovigilance system (in close cooperation with the client’s global PV system, EU-QPPV and the Deputy Local Person for Pharmacovigilance in the countries).
The Deputy takes over the responsibilities of the Local Person for Pharmacovigilance in case of absence.
As part of the Pharmacovigilance Team, located in the area of Mechelen, you will take the role for the Benelux region. You will be in charge of the management and investigation of adverse events. Your role also involves contact with the authorities for submissions, review of side effects, review of scientific literature, etc.
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures
Reviewing materials relating to local post-authorization safety
Integrated first Level Medical Information and PQC Support
You hold an University degree in Medicine, Pharmacy or Life Science
You have +4 years’ experience and profound knowledge in the field of pharmacovigilance
You have very good command of English and Dutch (mandatory). French is a plus.
You have a strong team spirit and you work in a collaborative way.
You have the sense of responsibility and a down-to-earth mentality
Our client offers a dynamic and ever evolving enterprise. You would have the chance to get involved in the company evolution.
Our client offers a full-time open-ended contract and good salary package and flexible advantages.