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Pharmacovigilance Manager

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Ellen Claes

Description de l'emploi

For one of our clients, based in Mechelen, we are looking for a pharmacovigilance manager

Your Job

  • Lead pharmacovigilance projects and coordinate project team activities
  • Implement and administrate PV systems
  • Write and update project related Safety Management Plans/Safety Data Exchange Agreements
  • Ensure case Management Process
  • Ensures local literature search activity
  • Review and update Periodic Safety Update Reports (DSURs/PSURs/PBRERs) as/if applicable
  • Under line manager supervision, interact with competent authorities as required
  • Interact with clients and ensure compliance
  • Contribute to the preparation of proposals as applicable in liaison with the line manager
  • Participate to audits and inspections in liaison with dedicated projects
  • Write and maintain up to date pharmacovigilance SOPs and instructions up to date
  • Perform weekly regulatory surveillance
  • Ensure compliance with the client procedures
  • Contribute to the preparation of presentations, webinars, blogs and posts
  • Acts as back up on other PV projects than dedicated as needed and providing appropriate transmission


Your Profile

  • Pharmacist or scientific graduation
  • 2 to 5 years of professional experience in the field of vigilance
  • Knowledge of relevant vigilance regulations and guidelines
  • Strong service orientation
  • Ability to manage more than one projects with limited guidance
  • Independent approach to work, flexibility and dedication
  • Diplomacy, ability to communicate and integrate in an international and multicultural environment
  • Strong sense of responsibility, organizational skills and motivation
  • English language fluency, written and spoken
  • Dutch fluency

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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
0499752248 Candidature spontanée