Job description Processing adverse events / serious adverse events or incidents with medicinal drugs / medical devices into the company safety database Inform immediately the local Health Authorities of any incident and immediately inform the local RP / QP Stay aware of local legislation and local legal requirements with regards to pharmacovigilance and materiovigilance and with regards to global and local procedural documents Ensure timely and accurate processing into safety database for recording, processing, following up and translation of AEs from spontaneous and solicited sources and SAEs from local interventional clinical studies, local non-
interventional studies and ES Ensure timely expedition of Targeted Safety Questionnaires to health care professionals for specific preferred event terms Perform reconciliation of safety event cases transmitted by external service providers or mentioned in specific system tools, as described in local SOP Identify local organised data collection programs in-
house twice a year Give advice to the local Clinical Operation colleagues / Medical Affairs Managers about relevant safety aspects in clinical trials or other safety programmes Job requirements Master’s Degree in Medical, paramedical or scientific field or equivalent experience Experience in Pharmacovigilance (through work experience or as a trainee) Trilingual : French, Dutch and English Benefits Challenging projects based on your interests and skills Personal follow-
up and clear, transparent communication both before and after commencement of employment Possibility to follow extra training Inspiring network events and legendary after work drinks Strong network of industry leading clients Expertise within IT, Engineering and Life Sciences A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees Please visit pauwelsconsulting.
com for more information about the vacancy Patient Safety Officer or apply for this job online through Patient Safety Officer.