Pharmacovigilance Officer and Compliance Coordinator

 

EUMEDICA SA is an international reference actor in the pharmaceutical sector. We offer to pharmaceutical companies a wide range of custom-made services in various domains such as regulatory affairs, distribution and promotion of pharmaceutical products as well as tailored logistics services.

Based in Manage, we are looking for talented and dynamic profiles to complete our teams and accompany us in our development.

 

Pharmacovigilance Officer and Compliance Coordinator

 

Description of the function:

Member of the Medical Affairs department, you will work with both our pharmacovigilance (4/5) and medical teams (1/5). As Pharmacovigilance Officer, you will be responsible for managing the PV cases on our products (from data collection to reporting). As Compliance Coordinator, you will manage and supervise the compliance of promotional activities in several European countries (no travel required).

 

You report directly to the Pharmacovigilance Manager / EU - QPPV.

 

Your responsibilities are :

  • Being responsible for day-to-day processing of incoming adverse event reports in compliance with the internal SOPs/WINs and GVPs
  • Where applicable, ICSR reporting to regulatory authorities and to partners within defined timeframe per local legislations and PV agreements
  • Performing the expectedness assessment as per local reference document and CCDS
  • Doing the medical assessment and writing of case narrative.
  • According to the priority in the department, you might be participating in other medical affairs/pharmacovigilance related activities.
  • Implement/Maintain and manage the quality system related to the compliance of promotional activities. Monitor the promotional activities (validate the promotional materials, ensure the compliance rules are followed by the sales team, report KPIs, …). Train the sales teams.

 

Your profile:

  • Master’s degree in a health-related or scientific discipline (medical/biomedical sciences, pharmaceutical sciences,…)
  • Experience in Drug Safety / Pharmacovigilance role is an asset
  • Work precisely as per procedures, rules and regulations (an experience in writing/reviewing SOP is an asset)
  • Good organizational & administrative skills
  • Structured, rigorous, attached to details and deadlines
  • Able to work autonomously and as a member of a cross-functional team
  • Must be able/motivated to meet the reporting deadlines
  • Curious and enthusiastic
  • Fluent in French, English (spoken and written). Dutch and German are assets
  • At ease with IT tools: Ms Office

 

We offer:

  • A full time long term contract
  • A salary package matching your competence
  • A very diversified job with many possibilities to develop your skills
  • A dynamic, ambitious and in development environment

 

Working place:

Eumedica s.a., Chemin de Nauwelette 1, 7170 MANAGE - BELGIUM