Pharmacovigilance Administrator

工作内容

Pharmacovigilance Administrator (Clinical trials activities)

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 and 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 of the distribution overviews per project following the most recent safety requirements
• Ensuring correct submission of SUSARs within regulatory timelines to: 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
• 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