Local Patient Safety Associate Benelux

Posted 03 Apr 2019

Amsterdam, Amsterdam - Netherlands

Req Id 189995


A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role: Our team is looking for a Local Patient Safety Associate Benelux, to be located in Overijse, Belgium or Amsterdam, Netherlands. In this role, you will be the local nominated person for pharmacovigilance in Belgium. With 2 recent launches in Immuno-Oncology and Neurology, and further upcoming launches, you will be part of a driven team, focusing on a complex and exciting Pharmacovigilance landscape. You will conduct product safety surveillance for our medicinal products for Belgium, the Netherlands and Luxemburg. This includes collection, registration, translation and transmission of individual case safety reports (ICSRs) to Global Patient Safety (GPS). You seek comprehensive initial information for all incoming cases and diligently perform follow-up on incomplete cases. 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 to ensure safety reporting procedures are in place. 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 appropriately trained and aware of PV regulations and their obligations.


Who you are:

  • 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

What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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