Medical Affairs Officer - Pharmacovigilance

Deadline for applications: 
Thursday, 30 September, 2021
Job description: 

Conduct pharmacovigilance, materiovigilance and cosmetovigilance in compliance with the current EU and national (BeNeLux) legislation:

  • Handling of post-marketing cases in clients’ local databases in compliance with client’s and Archemin’s procedures and applicable regulations.
  • Administrative tasks (archiving of the documents, reporting…).
  • Screen scientific literature and generate weekly reports
  • Follow-up of safety information including communication with the global pharmacovigilance department, and with the local reporters in Benelux and France.
  • Translation to English of information from cases from BeNeLux and France (NL, FR).
  • Conduct monthly reconciliation activities
  • Participate in the development and maintenance of the Archemin Pharmacovigilance quality system
  • Contribute to the 24/7 permanence service
  • At least a Bachelor’s Degree in life sciences
  • Candidates with proven experience in a comparable function or those who are familiar with the field's concepts, practices, and EU regulatory affairs procedures have an advantage.
  • Outstanding interpersonal and communication (written and verbal) skills are required: the ideal candidate is trilingual (Dutch / French / English) CEFR level B1 or higher.
  • Multitasker, able to cope with a broad range of projects, high stress levels and time pressure.
  • Diplomatic and flexible personality, proactive, being able to function alone and in a team.
  • Focused on detail and systematic in approach.
  • Proficient with computer and standard software programs (Word, Outlook, Excel,…).
  • Only candidates living in Belgium will be considered.
We offer: 
  • An environment where autonomy and entrepreneurship are stimulated.
  • The chance to participate in projects that influence the company strategy over the coming years
  • International context.
  • Salary dependent on relevant experience + extra-legal benefits.
  • A full-time function is offered
  • Applications + a detailed cv should be sent in Word format to hr [at] before the expiry date.
  • All applicants will receive a reply.
  • The procedure will involve one or more face-to-face interviews