For one of our clients located in the East of Brussels, we are actively looking for an enthusiastic (Junior) Pharmacovigilance Manager !
As Pharmacovigilance Manager, you are responsible for all pharmacovigilance and safety activities for a study, from study development until the archiving of the study.
You are responsible for day-to-day processing of incoming serious adverse event reports and, where applicable, expedited reporting to regulatory authorities within legal timeframes.
You ensure that all Pharmacovigilance activities are conducted in accordance with internal SOP’s, Good Clinical Practice guidelines and regulatory requirements.
You prepare the study specific SAE-form and guidelines.
You train site personnel on SAE reporting.
You attend project-based team meetings, phone conferences, and any other safety-related meetings.
You provide safety-related support to other teams during the study (data management, medical, regulatory, clinical operations, and project management).
You prepare the non-medical sections of the Development Safety Update Report and collaborate with the medical department for the production of the Safety Update Report.
You ensure the reporting of the Development Safety Update Report within the regulatory timelines.
You write SAE chapter of protocol and group-specific appendix during the protocol development.
You fully review the protocol and group-specific appendix before the start of the study.
You negotiate 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.
You attend the operational meetings with external partners.
You present the Pharmacovigilance Department to new staff members and to non-staff members.
You provide training to staff members on Pharmacovigilance.
You train (new) Pharmacovigilance Manager and (new) other Pharmacovigilance staff.
You ensure a back-up during absences of other team members (Pharmacovigilance Managers and the Head of Pharmacovigilance Department).
You perform other non-study specific pharmacovigilance tasks (internal quality checks, process development & improvement…).
You have a Master’s Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences,…)
You have a first experience in SAE processing/clinical safety/pharmacovigilance
You have a knowledge of clinical/pharmacovigilance regulations
You have a knowledge of safety database(s) and/or EudraVigilance submissions
You have good computer skills: MS Windows, Word, Outlook
You have good communication skills: fluent English (spoken and written)
You are able to work in a structured way
You are able to work in an independent way
You are able to speak in public
You are able to make decisions
You must be able to prioritize/motivated to meet the reporting deadlines
You must be a team player, with strong diplomatic skills