terug naar overzicht
Pharmacovigilance Manager is responsible for all pharmacovigilance and safety
activities for a study from study development until the archiving of the study.
This includes management of all information concerning serious adverse events
and serious adverse drug reactions in all studies where the company’s
Pharmacovigilance involvement is described in the protocol.
The Pharmacovigilance Manager is also responsible for protocol review,
negotiation/review of contracts, and representation of Pharmacovigilance
Department at internal and external meetings. The Pharmacovigilance Manager
provides support to the Head of Pharmacovigilance Department.
The Pharmacovigilance manager performs tasks for several studies as per
Pharmacovigilance latest SOP. This entails:
responsible for day-to-day processing of incoming serious adverse event reports
and, where applicable, expedited reporting to regulatory authorities within
- Ensuring that
all Pharmacovigilance activities are conducted in accordance with internal
SOP’s, Good Clinical Practice guidelines and regulatory requirements.
- Preparing the
study specific SAE-form and guidelines.
- Training site
personnel on SAE reporting.
project based team meetings, phone conferences, and any other safety related
safety related support to other teams during the study (data management,
medical, regulatory, clinical operations and project management).
- Preparing the
non-medical sections of the Development Safety Update Report and collaborating
with medical department for the production of the Safety Update Report.
- Ensuring the
reporting of the Development Safety Update Report within the regulatory
- Writing of
SAE chapter of protocol and group specific appendix during the protocol
- Full review
of protocol and group specific appendix before the start of the study.
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.
- Attendance to
operational meetings with external partners.
of the Pharmacovigilance Department to new staff members and non-company staff
- Master’s Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences,…)
- 2-5 years clinical safety/pharmacovigilance experience
- Knowledge of clinical/pharmacovigilance regulations
- Knowledge of safety database(s) and/or EudraVigilance submissions
- Good computer skills: MS Windows, Word, Outlook
- Good communication skills: fluent English (spoken and written)
- Ability to work in a structured and independent way
Contact us for more info: +32 16 30 95 09