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Pharmacovigilance Officer

09/10/2019
- Waver

Job content

We are on the lookout for a new team member to reinforce the pharmacovigilance departement. 

In collaboration with the other Pharmacovigilance (PV) staff members, this function will support activities related to pharmacovigilance, to ensure that all aspects of the local system are compliant with corporate and legal requirements.

Adverse Event (AE) handling and Reporting:

  • Receipt of individual case reports
  • Maintenance of the local AE database and tracking log
  • Reporting of cases in the Global Database
  • Internal communication of individual cases
  • CIOMS tracking and review of quality
  • Follow-up activities with the reporters
  • Documentation of cases in the individual case files.

Depending on the workload in the PV team and the profile of the candidate, this function may also be involved in other PV activities, such as training, procedures, periodic safety reports, compliance monitoring, changes in legislation, literature screening, agreements with service providers, audits and inspections, risk management, updates in product safety information, local studies,...

This function may occasionally also be involved in activities related to Regulatory Affairs and Quality Assurance to support other functions within the department.

Profile
  • Medical, pharmacy or life-sciences degree (or equivalent by experience).
  • Interest in the pharmaceutical industry and, in particular in pharmacovigilance / regulatory affairs / quality assurance. Prior experience is an asset.
  • Good knowledge of Dutch, French and English.
  • Dedication to work with tight timelines and accuracy, combined with flexibility to respond to changing environment and requirements.
  • Organizational skills, punctual, innovative, pro-active, flexible, team-player.
Contact

Please contact us for more information on +32 16 309 509 or marieke@arcq.be