Pharmacovigilance Manager

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Pharmacovigilance Manager


Functieomschrijving

The 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:

  • Being responsible for day-to-day processing of incoming serious adverse event reports and, where applicable, expedited reporting to regulatory authorities within legal timeframes.
  • 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.
  • Attending project based team meetings, phone conferences, and any other safety related meetings.
  • Providing 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 timelines.
  •  Writing of SAE chapter of protocol and group specific appendix during the protocol development.
  • Full review of protocol and group specific appendix before the start of the study.
  • Negotiation 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.
  • Presentation of the Pharmacovigilance Department to new staff members and non-company staff members.

Profiel

  • 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

Aanbod

Sollicitatieprocedure

Contact us for more info: +32 16 30 95 09


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Functiegroep:
Wetenschap
Regio:
Brussel
Sector:
Overige
Opleidingsniveau:
Master
Werkervaring:
Starter (0-2 jaar ervaring)
Type contract:
Contract Onbepaalde duur
Werkregime:
Voltijds