Pharmacovigilance Manager

Scope of the Job

The Pharmacovigilance Manager works under the hierarchical supervision of the Head of Pharmacovigilance Unit. Pharmacovigilance Manager reports on his/her activities and status of studies to the Head of Pharmacovigilance Unit.

Main responsibilities / Major Activities

It is the responsibility of the Pharmacovigilance Manager to manage all information concerning serious adverse events and serious adverse drug reactions in all studies where the EORTC Pharmacovigilance involvement is described in the protocol.

In addition, the Pharmacovigilance Manager provides support (protocol review, negotiation/review of contracts, representation of Pharmacovigilance Unit at internal and external meetings) to the Head of Pharmacovigilance Unit and serves as back-up for the Head of Pharmacovigilance Unit in case of absence.

Perform the task of Pharmacovigilance manager 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.
  • Performing quality checks on incoming safety information.
  • Requesting supplementary information whenever necessary and forwarding queries.
  • Asking advice and guidance to a medical doctor when information contained in an SAE report is unclear.
  • Encoding reports in the Pharmacovigilance Database and making sure that all information is updated and distributed appropriately within the specified timelines.
  • Attending project based team meetings, phone conferences, any other safety related meetings.
  • Providing support to data management during the SAE reconciliation/overseeing SAE reconciliation.
  • Helping in the production of the Development Safety Update Report.

Assisting the Head of Pharmacovigilance Unit. This entails:

  • 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.
  • Participation in projects to improve the SAE management.
  • Review and/or update WINs and SOP of the Pharmacovigilance Unit.
  • Writing specific guidelines.
  • Presentation of the Pharmacovigilance Unit to new EORTC staff members and non-EORTC staff members.
  • Training of EORTC staff members on some PVU training modules.
  • Training (new) Pharmacovigilance Manager
  • Training (new) Pharmacovigilance Secretary

Other responsibilities

  • Back-up during absences of the Head of Pharmacovigilance Unit

Profile

  • Master’s Degree in Life Sciences (medical sciences, pharmaceutical sciences,…)
  • 5 years SAE processing/clinical safety/pharmacovigilance experience
  • Must have good computer skills: MS Windows, Word, Outlook
  • Must have (bio)medical/scientific background
  • Needs good communication skills: fluent English (spoken and written)
  •  Ability to work in a structured way
  • Ability to work in an independent way
  • Ability to speak in public
  • Ability to make decisions
  • Must be able to prioritize/motivated to meet the reporting deadlines
  • Must be a team player, strong diplomatic skills

The EORTC offers a highly stimulating, professional & friendly atmosphere in an international environment, and employees’ benefit.
Please send curriculum vitae and cover letter in English to:
Recruitment – EORTC
Avenue E. Mounier 83, box 11, 1200 Brussels, Belgium
Confidential fax: +32 2 770 78 11
Email: recruitment@eortc.be

 

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