Scope of the Job
Main responsibilities / Major Activities
- Being responsible for day-to-day processing of incoming serious adverse event reports and, where applicable, expedited reporting to regulatory authorities within legal timeframes.
- Ensuring that all Pharmacovigilance activities are conducted in accordance with internal SOP’s, Good Clinical Practice guidelines and regulatory requirements.
- Preparing the study specific SAE-form and guidelines.
- Performing quality checks on incoming safety information.
- Requesting supplementary information whenever necessary and forwarding queries.
- Asking advice and guidance to a medical doctor when information contained in an SAE report is unclear.
- Encoding reports in the Pharmacovigilance Database and making sure that all information is updated and distributed appropriately within the specified timelines.
- Attending project based team meetings, phone conferences, any other safety related meetings.
- Providing support to data management during the SAE reconciliation/overseeing SAE reconciliation.
- Helping in the production of the Development Safety Update Report.
- Writing of SAE chapter of protocol and group specific appendix during the protocol development.
- Full review of protocol and group specific appendix before the start of the study.
- Negotiation and review tasks and responsibilities, contract, PV agreement, cooperation document and other applicable documents in order to have clear procedures in place before the start of the study.
- Attendance to operational meetings with external partners.
- Participation in projects to improve the SAE management.
- Review and/or update WINs and SOP of the Pharmacovigilance Unit.
- Writing specific guidelines.
- Presentation of the Pharmacovigilance Unit to new EORTC staff members and non-EORTC staff members.
- Training of EORTC staff members on some PVU training modules.
- Training (new) Pharmacovigilance Manager
- Training (new) Pharmacovigilance Secretary
- Back-up during absences of the Head of Pharmacovigilance Unit
- Master’s Degree in Life Sciences (medical sciences, pharmaceutical sciences,…)
- 5 years SAE processing/clinical safety/pharmacovigilance experience
- Must have good computer skills: MS Windows, Word, Outlook
- Must have (bio)medical/scientific background
- Needs good communication skills: fluent English (spoken and written)
- Ability to work in a structured way
- Ability to work in an independent way
- Ability to speak in public
- Ability to make decisions
- Must be able to prioritize/motivated to meet the reporting deadlines
- Must be a team player, strong diplomatic skills
Please send curriculum vitae and cover letter in English to:
Recruitment – EORTC
Avenue E. Mounier 83, box 11, 1200 Brussels, Belgium
Confidential fax: +32 2 770 78 11