Pharmacovigilance Manager

at  EORTC

The Pharmacovigilance department is seeking a Pharmacovigilance Manager to strengthen its team. The Pharmacovigilance Manager will report directly to the Head of Pharmacovigilance.
Main responsibilities / Major Activities
Ensures that Serious Adverse Events are handled according to the pharmacovigilance latest SOP (Standard Operating Procedure)
By preparing the SAE-form/e-SAE forms and guidelines and providing them to the Data Manager of the study
Preparing the requirements for the database pertaining to PV and performing the user acceptance testing
By checking that in Pharmacovigilance Department all documents are available and that all procedures are clear at the study opening and after any amendment
By performing quality checks on incoming safety information
By requesting supplementary information whenever necessary and forwarding queries
By asking advice and guidance to a medical doctor when information contained in a SAE report is unclear
By managing the new report in the Pharmacovigilance Database
By processing reports electronically once they are in electronic systems
By making sure that all information is updated and distributed appropriately within the specified timelines
By tracking all requests based upon regulatory deadlines
By being responsible of safety reporting to competent authorities, ethics committees and investigators
By informing the Pharmacovigilance Administrator when a case or Development Safety Update Report is reportable based upon latest reporting requirements document
By reporting SAEs, line listings and other safety information to appropriate persons and entities
By reviewing SAE-summaries, cover templates and other documents prepared by the Pharmacovigilance /staff
By attending project based team meetings, phone conferences and any other safety related meetings
By giving support to Clinical Data Manager during the SAE reconciliation
By preparing the Development Safety Report for medical writing, providing information for the medical author and finalizing the report
Ensures that the individual case safety reports are accurate, complete and timely managed for regulatory reporting purposes.
Performs PV legislation monitoring
Make searches for European Union and country specific safety reporting requirements. Records the requirements in Pharmacovigilance files. Ensures the accuracy of the safety reporting requirements by maintaining the knowledge of the safety reporting requirements.
Other tasks
Contributes to the protocol development: attends phone conferences and meetings (team and external partners), completes the Pharmacovigilance section of the protocol. Writes and reviews the Pharmacovigilance content of the group specific appendix when appropriate
Reviews and negotiates the safety agreement and contract
Prepares and participates in internal and external audits/inspections
During the study contributes to requests by other EORTC teams (medical, regulatory, clinical operations, data management, contracts and project management)
Gives presentations of Pharmacovigilance Department to new EORTC staff members and to non-EORTC staff members
Gives pharmacovigilance trainings to EORTC staff members and to non-EORTC staff members
Performs and gives contribution to non-study specific pharmacovigilance tasks
Profile
Master’s Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences,….)
2-5 years SAE processing/clinical safety/pharmacovigilance experience
Knowledge of clinical/pharmacovigilance regulations
Knowledge of safety databases and EudraVigilance submissions
Good communication skills: fluent English (spoken and written)
Ability to work in a structured way and independent way
Must be able to prioritize/be motivated to meet the reporting deadlines
Must be a team player, with strong diplomatic skills
Common and good IT knowledge like Microsoft Office
Benefits
Permanent contract
Homeworking allowance
Reimbursement of public transport
Pension plan
Hospitalisation insurance and ambulatory care
Meal vouchers
Free parking
Wage according to our Non-Profit organisation status
30 days holidays (full time)
Hybrid working environment (from Belgium only

Please refer the Job description for details