Assistant to QA Coordinators and ERB chair - Brussels

Location: Brussels
Duration: Long-term contract
100% Full time position
Reporting to International Pharmacist Coordinator (IPC), the QA Coordinator for Medical Devices, the International Food QA Coordinator, and the Chair of the ERBxx
Starting date: As soon as possible
Deadline for applications 28 February 2015



Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters. MSF offers assistance to people based only on need and irrespective of race, religion, gender or political affiliation.

MSF International is the legal entity that binds MSF’s 21 sections, 24 associations and other offices together. Based in Geneva, MSF International provides coordination, information and support to the MSF Movement, as well as implements international projects and initiatives as requested.


MSF has established a standardised approach to ensure the quality assurance (QA) of the medical products used in our projects (medicines, medical devices and specialised medical food). This approach relies on other approval systems such as WHO prequalification or registration in countries with stringent health regulatory authorities and performs the full evaluation of the quality of the products not covered by existing systems. For vaccines, MSF relies on the WHO prequalification.

MSF has also an Ethics Review Board (ERB) comprising 8 to 10 members, and a chair; all external to MSF. The ERB reviews all operational research projects filling the criteria for submission by the medical directors.


The Assistant will be part of the International Office (IO) medical team, coordinated by the International Medical Coordinator.
Reporting lines: The Assistant reports to the International Pharmacist Coordinator (IPC), the QA Coordinator for Medical Devices, the International Food QA coordinator, and the Chair of the ERB.


The Assistant will manage the databases for medical products, the ERB database and give some administrative and logistical support to the 3 QA coordinators and the ERB Chair.

Each of the components of this role are of varying intensity during the year and over the years to come, in line with the development of the MSF codification project and the revised database for medical products.

Currently there is an operational pharmaceutical database that should be maintained and prepared for transfer into the new version. After this transfer, the role of the Assistant will still be to update the database with regular updated information, even though more pharmacists will also input data in the database. For medical devices, the database needs to be developed based on the model of the pharmaceutical one, and for specialised food items, the database is currently maintained by the International Food QA Coordinator. Both medical devices and specialised food databases will progressively develop following the same model as the pharmaceutical one.

The ERB database needs to be maintained with approximately 40 research protocols to review per year.


Maintain the Quality Assurance databases (pharmaceutical, medical devices and specialised food) and the ERB data base and administer the MSF & ERB document repository systems

keep the content of the data bases updated

  • for the 3 QA databases: centralise all the information (dossiers, audit, reports, PASS, PSS, DOE, correspondence, review, and according to requirement, claim, batch recall etc), when needed enter it into the database and make sure it is available for the pharmacists involved (eg ESC pharmacists)
  • for the ERB data base: maintain a database on all MSF research projects involving human participants submitted to the ERB; include follow up after ethical approval (request for amendments, final report, publications and other relevant information); the ERB database, shall document the current status of all research proposals submitted to the ERB (e.g., whether exempt from review, approved, awaiting changes before action, or not approved)

Prepare and maintain documentation

For the 3 QA:

  • Perform a first dossier screening at reception for completeness in support of the 3 QA Coordinators,
  • Codify/archive the product dossier and audit reports (print / electronic versions), bioequivalence studies, products samples, manage the PSS and DOE lists
  • Archive and reference documents and emails regarding the qualification of products (validation/devalidation emails, relevant summary tables such as the disease focused ones)
  • Support QA Coordinators in implementing and maintaining the quality management system
  • Support QA Coordinators to ensure that quality assurance records, files, data and other documentation is organized and managed efficiently.

For the ERB:

  • Undertake a preliminary review of all submitted proposals to assess whether the proposal is complete (according to the ERB check list) and if it qualifies for expedited or full review  
  • Maintain the following documentation: terms of reference of the ERB, up-to-date list of all ERB Members with their terms of service, titles, and curricula vitae or other biographical information sufficient to describe their qualifications (e.g., educational background, current employer, and relevant area(s) of expertise); full set of reports of ERB meetings; copies of all research proposals submitted to ERB, including comments from any scientific or technical bodies and other research ethics committees (RECs) that reviewed any such proposal.; archives of ERB activities since its inception
  • Maintain the document repository for ERB members
  • Draft the annual activity report

Support the 3 QA Coordinators and the ERB chair in the following activities:

With the 3 QA Coordinators:

  • Organize and follow-up of all QA evaluation steps
  • Prepare, organize and follow-up international GMP audit of manufacturing sites
  • Follow up product dossiers
  • For medicines
    • Organize the International Medicines Evaluation Sessions (IMES), allocate reviewers team, track deadlines, etc.
    • Handle the BE studies: print and send them to expert, archive them
    • Surveillance of the official websites (WHO-PQ, USFDA, Eudra GMP, etc.) on  pharmaceutical information, recall, variation or any new facts

With the ERB Chair:

  • Ensure that reviews of new research proposals, and continuing review of all previously approved research proposals, are carried out promptly through follow-up with the chair and ERB members

Administrative support :

For the 3 QA Coordinators:

  • Organize meetings when requested:
    • Book the room, send the invitations to participants, update the lists of participants…
    • Take minutes of meetings when requested
  • Support to IPC (International Pharmacist Coordinator):
    • In follow up of human resources (pharmacist contact list, holiday overview, sharing of information about pharmacist country visits)
    • Organize pharmaceutical mailing lists: google groups (MSF international and IMES) as well as access rights to document repositories
    • Follow-up yearly subscriptions (US Pharmacopeia, BP Pharmacopeia) and update pharmaceutical reference list regularly
    • Distribution of pharmaceutical data and documents within the MSF pharmaceutical network
    • Review the pharmaceutical folders in document repositories and support the IPC in maintaining and updating in document repositories folders
  • Administrative support to translation when needed
  • Can be the administrative back-up in case of absence

For the ERB Chair:

  • Keep track of timelines, work load of each ERB member and active participation in the review process
  • Ensure any administrative assistance that may be needed by the Chair and Members in carrying out the ERB’s functions
  • Support the chair in organizing ERB meetings, including drafting of the meeting report
  • Make readily available information to MSF staff about the ERB, including its standards, rules, procedures, activities and meeting reports

Logistical support:

  • Travel arrangements, hotel booking and logistics support to the 3 QA Coordinators, the ERB Chair, and to external experts
  • Undertake other duties as required


  • Genuine interest in, understanding of, and commitment to the humanitarian principles and challenges of MSF
  • Fluent written and spoken English and French
  • Very good English writing skills
  • Experienced in database management
  • Experienced in Quality System Management
  • Experience in pharmaceutical environment a plus
  • Knowledge of medical/public health matters, preferably in a humanitarian / development environment.
  • Understanding of research would be ideal
  • Previous experience in similar position
  • Software skills: Word, Power Point, Excel
  • Able to work with the necessary precision and rigor requested
  • Flexibility, availability, ability to travel


Location: Brussels
Duration: Long-term contract
100% Full time position
Reporting to International Pharmacist Coordinator (IPC), the QA Coordinator for Medical Devices, the International Food QA Coordinator, and the Chair of the ERBxx
Starting date: As soon as possible
Deadline for applications 28 February 2015

Please submit all applications only by email to: stating
“Assistant to QA Coordinators and ERB Chair” in the title.

Please submit only ONE file containing your CV and motivation letter and name the file with your LAST NAME only.

Only short-listed candidates will be contacted