Pharmacovigilance Administrator

The EORTC Pharmacovigilance department is looking for a full-time Pharmacovigilance Administrator to reinforce its team.
The Pharmacovigilance Administrator (PVA) works under the hierarchical supervision of the Head of Pharmacovigilance.

Main responsibilities / Major Activities
The Pharmacovigilance Administrator is responsible for administrative and reporting tasks in the Pharmacovigilance department including other supportive tasks upon request.
PVA’s main task is the submission of safety reports to regulatory bodies in compliance with European and/or national laws and regulations.
Serious Adverse Event handling (SAEs)
Encoding administrative data in the safety database upon request of the Pharmacovigilance Manager (PVM)
Performing SAE distribution upon request of the PVM
Checking the pending queries and sending reminders to the investigators and entitled site personnel
Preparing all relevant SAE information for the monitoring visits upon request of the Clinical Research Associate (CRA)
Suspected Serious Adverse Reactions (SUSARs) and other safety reports
Maintaining the distribution overviews per project following the most recent safety requirements
Ensuring correct submission of SUSARs within regulatory timelines to the Eudravigilance Clinical Trials Module, competent authorities (CAs), ethics committees (ECs), investigators and other appropriate parties as per agreement
Ensuring correct submission of other safety reports as per regulations
Filing of SUSARs and other safety reports distribution documentation and managing acknowledgements of receipt as per TMF (Trial Master File) and other internal procedures
Development Safety Update Reports (DSURs)
Maintenance of the distribution overviews per project following the most recent safety requirements
Preparing the DSUR which will be further developed by the Pharmacovigilance & Medical team
Ensuring that all team members respect the internal deadlines during the DSUR preparation
Managing the signature process of the final DSUR
Ensuring correct submission of DSURs within regulatory timelines to competent authorities (CAs), ethics committees (ECs) and other appropriate parties as per agreement
Filing of DSUR distribution documentation and managing acknowledgements of receipt as per TMF (Trial Master File) and other internal procedures
Managing DSUR invoices in collaboration with PVM and HoPV

**Other responsibilities**:
Management of Safety reporting requirements by maintaining the safety reporting requirements list and supporting the PVM in searching the latest information
Management of the PV department documents
Quality-related tasks as assigned
Providing support to the PV Team in various administrative tasks including meeting arrangements
Profile
Bachelor’s degree or experience in an administrative position
A life science background is an asset
Strong command of the English language and good writing skills
Excellent attention to detail and accuracy
Demonstrated good organization, communication and time-management skills
Ability to cope with and meet tight timelines when required

**Benefits**:
Permanent contract
Competitive salary package
Hybrid working environment (from Belgium)
30 days holidays (full time)
Meal vouchers
Pension plan
Hospitalisation insurance and ambulatory care
Homeworking allowance
Reimbursement of public transport
Free parking