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(Junior) Pharmacovigilance Manager

For one of our clients located in the East of Brussels, we are actively looking for an enthusiastic (Junior) Pharmacovigilance Manager !

Job description

As Pharmacovigilance Manager, you are responsible for all pharmacovigilance and safety activities for a study, from study development until the archiving of the study.

Responsibilities 

  • 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…).

Requirements

  • 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