The Company:
Our client is a leading biotech company located in Breda, Netherlands. They are committed to innovation and improving patient outcomes through their cutting-edge research and development in the biotechnology sector.
 
Role Description:
As a Safety Associate, you will play a crucial role in ensuring the safety of patients using our products. You will process, monitor, and follow up on adverse event reports from clinical trials (CT), spontaneous reports (SR), and patient support programs (PSPs). Your primary focus will be ensuring that healthcare professionals (HCPs) are contacted to obtain additional information about adverse events, as well as managing associated correspondence and documentation in compliance with local and global safety regulations.
 
Responsibilities:
-Monitor and resolve action items in the Safety Database assigned to the Netherlands safety group.
-Send out letters to Dutch healthcare professionals (HCPs) to obtain additional information on adverse events reported during PSPs.
-Distribute additional risk minimization measures (aRMMs) and process received follow-up letters.
-Accurately process adverse events reported to the affiliate from all sources (letters, email, phone) into the Global Safety Database.
-Ensure timely submission of reportable adverse drug reaction reports and distribute periodic safety or urgent safety communications per local regulations and company procedures.
-Collaborate with the Safety Manager and Senior Safety Associate to uphold local operating performance standards and reporting compliance.
-Facilitate the exchange of adverse event information with functional service providers, following established agreements.
-Participate in corrective and preventive actions (CAPAs) to resolve local issues.
-Ensure the department remains inspection-ready by adhering to local quality assurance measures.
 
Requirements:
-MBO+ or HBO degree
-Strong administrative experience and proficiency in Microsoft Office
-Fluent in Dutch and English
-Attention to detail and strong organizational skills
-Excellent communication skills and a proactive mindset
-Team player with a customer-oriented approach
-Computer literacy, including familiarity with databases
 
Other Information:
This is a part-time role (24 hours/week). The Safety Associate is expected to work in a hybrid mod, will need to be present at the Breda office at least one day per week. This position offers an excellent opportunity to contribute to patient safety within a collaborative environment.

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