Do you have pharmacovigilance experience and willing to take the next step in your career ? We are looking for a pharmacovigilance manager to join our client located in Brussels ! This permanent position at our client combines days on site in Brussels and days working remotely.
The Pharmacovigilance Manager works under the hierarchical supervision of the Head of Pharmacovigilance.
Ensures that Serious Adverse Events are handled according to what is described in the Pharmacovigilance latest SOP :
- By preparing the SAE-form/e-SAE forms and guidelines and providing them to the Data Manager of the study.
- 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 to 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 Data Manager during the SAE reconciliation.
- By helping in the production of the Development Safety Update Report by preparing the non-medical parts of the Development Safety Report and by providing information for the medical author.
Other responsibilities :
- 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 the safety agreement and contract.
- During the study contributes to requests by other teams (medical, regulatory, clinical operations, data management, contracts and project management).
- Gives presentations of Pharmacovigilance Department to new staff members and to non staff members.
- Gives pharmacovigilance trainings to staff members and to non staff members.
- Performs and gives contribution to non-study specific pharmacovigilance tasks.
- 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 data base(s) and/or 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/motivated to meet the reporting deadlines
- Must be a team player, strong diplomatic skills
- Existing right to work in Europe required
- Permanent contract
- 30 days Holidays
- Competitive Salary Package
- DKV hospitalization employer
- Free parking
- Full hybrid
- Full reimbursement public transport
- Meal vouchers
- Pension plan
Vacancy number : 20362