Pharmacovigilance Manager

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

Homeworking allowance

Reimbursement of public transport

Pension plan

Hospitalisation insurance and ambulatory care

Free parking

Wage according to our Non-Profit organisation status

30 days holidays (full time)

Hybrid working environment (from Belgium only)

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