Safety Officer

Key responsibilities

  • Comply with vigilance best practices and provide input to contribute to the evolution of the departments activity
  • Stay ahead of changes in regulatory requirements in relation to safety (pharmacovigilance and materiovigilance)
  • Ensure that all safety information is efficiently handled and submitted within the legally defined timelines according to standard operating procedures and working instructions
  • 24/7-call handling and administration
  • Case processing
  • Literature screening
  • Assist, review or draft aggregate reports
  • Participate in self-inspections and audits
  • Develop and deliver training regarding vigilance procedures to staff and contractors
  • Interact with the Regulatory Affairs & Quality Assurance department

Regulatory Affairs Officer

Key responsibilities

  • Assist and support the Regulatory Affairs department
  • Prepare, verify and adapt product information
  • Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
  • Submit registration and notification dossiers to health authorities
  • Manage the life cycle of the client portfolios (variations, renewals…)
  • Proofread leaflets and labeling
  • Support evaluation of promotional activities
  • Maintain records and files