infarAMA is currently looking for a

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

Quality Assurance Officer

Key responsibilities

  • Support the Quality Assurance (QA) department
  • Prepare the administrative release of finished products (medicinal products/medical devices)
  • Follow-up on the implementation of new artwork
  • Evaluate the destination of returned products
  • Handle product complaints and deviations
  • Assist in activities related to final product release by the QP (review batch documentation)
  • Write and implement standard operating procedures according to customer specifications
  • Ensure compliance with all applicable GDP/GMP regulations
  • Prepare and provide adequate training regarding QA procedures to staff and contractors
  • Participate in self-inspections and audits
  • Prepare quality variation dossiers in cooperation with the Regulatory Affairs department
  • Manage the QA documentation

Required profile

  • Scientific degree (pharmacist, biomedical science or equivalent by experience)
  • 2 years of relevant experience in a similar function in the pharmaceutical industry
  • Fluent in English, Dutch and French with excellent oral and written communication skills
  • Strong knowledge of current software
  • Meticulous, methodological, enthusiastic, flexible and reliable
  • Able to work both independently and in teams

Offer

  • A varied job with challenging multi-disciplinary tasks in a dynamic and growing environment
  • Competitive benefits and compensation packages
  • Workplace in Aarschot or in Strombeek-Bever

Applications

Interested? Send your resume and application letter to p.vandenweghe@infarama.be.

For more information, feel free to contact us.