Junior Pharmacovigilance Manager

The Junior Pharmacovigilance Manager works under the hierarchical supervision of: Head, Pharmacovilance Department and under the direct guidance by Senior Pharmacovigilance Manager. In case of unavailability of the Senior Pharmacovigilance Manager, Pharmacovigilance Manager gives guidance.
Objective
To process and submit individual and periodic safety case reports under responsibility of EORTC according to appropriate legislation and according to EORTC procedures. Contributes to other study related pharmacovigilance tasks under review and guidance of more senior staff in the Pharmacovigilance Department. To perform or give input to non-study specific pharmacovigilance tasks in the Department.
Main responsibilities / Major Activities
Manages the Serious Adverse Events according to the latest Standard Operation Procedures (SOP). Contributes to periodic safety reports under review by more senior staff.
**Under review by more experienced pharmacovigilance staff**:
May contribute to other study-specific pharmacovigilance tasks.
May perform and contribute to non-study specific pharmacovigilance tasks.
May contribute to maintenance and development of country-specific pharmacovigilance reporting requirements within and outside EU. Contributes to ensuring acccuracy of safety reporting requirements by maintaining the knowledge of them.
Major Activities
Prepares the SA/e-SAE forms and guidelines and provides them to the Clinical Data Manager of the study.
Prepares the requirements for the database pertaining to PV and performing the user acceptance testing.
Checks that in Pharmacovigilance Department all documents are available and that all procedures are clear at the study opening and after any amendment.
Performs quality checks on incoming safety information.
Queries and requests supplementary information whenever necessary.
Asks advice and guidance to a medical doctor when information is contained in a SAE report is unclear.
Manages the new report in the Pharmacovigilance Database.
Processes reports electronically once they are in electronic systems.
Makes sure that all information is updated and distributed appropriately within the specified timelines.
Tracks all requests based to regulatory deadlines.
Is responsible for safety reporting to competent authorities, ethics committees and investigators.
Informs the Pharmacovigilance Administrator when a case or a Development Safety Update Report is reportsbale based upon latest requirements document.
Reports SAEs, line listings and other safety information to appropriate persons and entities.
Reviews SAE summaries, cover templates and other documents prepared by the Pharmacovigilance staff.
Attends project-based team meetings, phone conferences, and any other safety related meetings.
Gives support to Clinical Data Manager during SAE reconciliation.
Prepares 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.
**Under review, may**:
Contribute to searches for European Union and country specific safety reporting requirements and recording them into the records of Pharmacovigilance files. Contributes to ensuring accuracy of the safety reporting requirements by maintaining the knowledge of the safety reporting requirements.
**Contribute to the protocol development**: attends phone conferences and meetings (team and external partners), completes the pharmacovigilance secton of the protocol. Writes and reviews the pharmacovigilance content of the group specific appendix when appropriate.
Contribute to reviews and negotiations on the safety agreement and contract.
Contribute to preparations for internal and external audits/inspections.
During the study, contribute to requests by other EORTC teams (medical, regulatory, clinical operations, data management, contracts and project management).
ContrIbute to pharmacovigilance trainings provided by the EORTC Pharmacovigilance.
Perform and give contibution to non-study specific pharmacovilance tasks.
Profile
Bachelor/Master’s Degree in Life Sciences(medical/biomedical/pharmaceutical sciences, )
0 - 2 years SAE processing/clinical safety/pharmacovigilance experience
Knowledge of clinical/pharmacovigilance regulations is a benefit
Knowledge of pharmacovigilance databases and EudraVigilance submissions/ capacity to work with databases
**Good communication skills**: fluent English (spoken and written)
Ability to work in a structured way, capacity to work independently
Must meet reporting timelines, must have prioritization skills
Team player, strong diplomatic skills
**Strong IT skills**: Microsoft Office and other common IT tools

**Benefits**:
30 days holidays (full time)
Wage according to our Non-Profit organisation status
Hospitalisation insurance and ambulatory care
Free parking
Reimbursement of public transport
Hybrid working environment