Our team is looking for a Local Patient Safety Associate Benelux, to be located in Overijse, Belgium. In this role, you will be the local nominated person for pharmacovigilance. You will conduct product safety surveillance for our medicinal products for Belgium, the Netherlands and Luxemburg. This includes collection, registration, translation and transmission of ICSRs to Global Patient Safety (GPS). You will also screen the relevant scientific literature and websites of health authorities to identify and retrieve safety information about our medicinal products. You work in close collaboration with medical information, quality assurance and complaint management. You regularly reconcile the received case reports across functions. You will monitor local compliance with ICSR processing timelines and compile compliance reports within the existing global tools. You support the Support Center Manager, located in Amsterdam, in order to have a complete overview on Patient Data Collection Systems (PDCS) and that global procedures for PDCS are followed. In this role, you will also ensure that all local staff is trained.
- You have a University Degree in pharmacy or life science, medical documentation or similar, alternatively you are certified as Nurse
- You have gathered 3+ years experience in pharmacovigilance, any additional experience in clinical trial safety is beneficial
- You have a good working knowledge of GVP, additional knowledge in GCP, GxP is beneficial
- You are fluent in Dutch and French for communication with reporters of safety information and fluent in English
- You have a proven track-record of cross-functional collaboration and a pragmatic and team-oriented working style
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