The Company
Our client is a global leader in biopharmaceutical innovation, dedicated to improving patient outcomes through groundbreaking therapies. With a strong presence in Breda, their Dutch affiliate focuses on delivering patient-centric safety solutions, ensuring compliance, and maintaining the highest quality standards in pharmacovigilance.
 

The Role
As an Associate Global Safety, you will play a pivotal role in the Local Pharmacovigilance team, ensuring patient safety by managing adverse event data and maintaining compliance with regulatory and organizational standards. This position is essential for supporting the Patient Support Programs (PSPs), ensuring timely communication with healthcare professionals (HCPs), and fostering a culture of safety and vigilance.
 

Responsibilities
– Log into the Safety Database to manage tasks related to PSPs, clinical trials, and spontaneous reports.
– Identify healthcare professionals (HCPs) linked to adverse events and send tailored correspondence to request additional information.
– Process and distribute additional risk minimization measures (aRMMs) and handle follow-up letters.
– Ensure accurate and timely local processing of adverse event reports, facilitating their entry into the Global Safety Database.
– Submit adverse drug reaction reports and distribute safety communications per regulatory and company requirements.
– Collaborate with the Safety Manager and Senior Safety Associate to maintain compliance and resolve local safety issues through CAPAs.
– Ensure inspection readiness and maintain local quality assurance measures.
 

Requirements
– Fluent in Dutch and English, both written and spoken.
– Availability to work part-time (24 hrs/week) with flexibility and at least one in-office day per week.
– MBO+ or HBO degree, preferably in a scientific or administrative discipline.
– Strong administrative skills with proficiency in Microsoft Office and familiarity with databases.
– Exceptional attention to detail, organizational, and communication skills.
– A proactive, team-oriented mindset, with customer-focused problem-solving abilities.
 

Other Information
This role offers a unique opportunity to contribute to global patient safety initiatives within a collaborative and dynamic environment. It is a maternity cover part-time temporary role, ideal for a detail-oriented professional passionate about ensuring compliance and supporting patient safety programs.
Apply today to make an impact!

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