Medical Safety Manager - Mechelen - BE or Leiden - NL

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen),  Switzerland (Basel),  the Netherlands (Leiden) and in US, Boston.

We’re in the business of changing lives.  In our quest to discover and develop life-improving medicines we go where no one has ever gone before.   In every challenge we face, we see new opportunities.  We want to challenge the impossible.  We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.  Collaborative innovators and perseverant idealists. We need the best-in-class.  In other words, we need you: The ‘make-it-happeners’. 


We are looking for a Medical Safety Manager.

Scope of the job:

Acting for global Medical Safety of Galapagos across the company portfolio of all investigational and marketed products, focusing in the processes control, interactions with the country organizations, training to the Medical Safety Department team members as well as to all involved in the Medical Safety activities actors from other Galapagos Departments or external vendors. Overseeing continuous quality control at different levels of the processes in place in the department, actively contributing to company’s compliance to the Pharmacovigilance regulations and by extension to the guarantee of the safety of all participant’s in Galapagos clinical studies.

Your role:

  • Support the EU-QPPV by running the QPPV Office structures
  • Coordinate PSMF development in collaboration with the EU-QPPV
  • Create and maintain interfaces with country organizations on all PV related matters
  • Provide trainings, in collaboration with the Training Department, to all concerned Galapagos Departments and external vendors
  • Identify the needs of SOP/WI of Medical Safety Department, initiate and coordinate their writing and implementation
  • Integrate the safety scientific component to build a strategic framework for clinical development plans
  • Collaborate with the external service providers delivering pharmacovigilance services and any other Safety related documents, ensure PV vendor oversight


Job requirements

Who are you?

  • Master / PhD degree with 5 years relevant experience in drug safety
  • Able to fluently read, write, understand and communicate in English
  • The regulatory landscape has no secrets for you, in particular for PV-related matters
  • Proven ability to drive the change, improve processes and manage people in drug safety
  • Demonstrated attention to detail, strategic thinking and problem solving skills
  • Able to work under stress, demonstrating initiative and flexibility.

What’s in it for you ?

 You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.


We are Galapagos : together we can make it happen…!