Assistant to QA Coordinators and ERB Chair
Assistant to Quality Assurance Coordinators and Ethics Review Board Chair
I. MSF International
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 19 sections, 23 associations and other offices together. Based in
II. Position background
MSF has established a standardised approach to ensure the quality assurance (QA) of the medical products we use 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 drug regulatory authorities and performs the full evaluation of the quality of the products not covered by existing systems. For vaccines, we rely on the WHO prequalification.
MSF has also an Ethics Review Board (ERB) composed of 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.
III. Place in the organisation
The assistant will be part of the International Office (IO) medical team, coordinated by the International Medical Coordinator.
The position reports to the:
- International Pharmacist Coordinator (IPC);
- QA Coordinator for medical devices;
- QA Coordinator for specialised medical food; and
- Chair of the ERB.
IV. Objectives of the position and foreseen evolution
The assistant will manage the databases for medical products, the ERB database and provide administrative and logistical support to the 3 QA coordinators and the ERB Chair.
The relative weighting of the components of this role will vary during the year and will change 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 medical food items, the database is currently maintained by the specialised medical food QA coordinator. Both the medical devices and specialised medical food databases will develop progressively following the same model as the pharmaceutical one.
The ERB database needs to be developed and maintained with approximately 40 research protocols to review per year.
V. Main responsibilities
1. Maintain the Quality Assurance databases (pharmaceutical, medical devices and specialised medical food) and the ERB data base:
i. Keep the content of the data bases up to date
- for the 3 QA databases: centralise all the information (dossiers, audit, reports, specific forms as PASS, PSS, correspondence, review, 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: develop and 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 will 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)
2. Prepare and maintain documentation
i. For the 3 QA:
- On reception of a dossier perform a first screening for completeness,
- codify/archive the product dossier and audit reports (print / electronic versions), bioequivalence studies, products samples, manage the PSS lists
- Archive and reference documents and emails regarding the qualification of products (validation/devalidation emails, relevant summary tables such as the disease focused ones)
ii. For the ERB:
- Undertake a preliminary review of all submitted proposals to assess whether the proposal is complete (according to 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
3. Support the 3 QA Coordinators and the ERB Chair in the following activities:
i. With the 3 QA Coordinators:
- Organize and follow-up of all QA evaluation steps:
a. Prepare, organize and follow-up international GMP audits of manufacturing sites
b. For medicines
- Organize the International Medicines Evaluation Sessions (IMES), allocate reviewers team, track deadlines, etc.
- Handle the Bio equivalence (BE) studies: print and send them to the expert, and archive them
- Send and follow-up documents to external experts for assessment
- Prepare IPC Quality Assurance annual reviews by section pharmacists
- Surveillance of the official websites (WHO-PQ, USFDA, Eudra GMP, …) on pharmaceutical information, recall, variation or any new facts
ii. 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
4. Administrative support
- For the 3 QA Coordinators:
i. Take minutes of meeting when requested
ii. Support the IPC:
- 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)
- 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 under Tukul and support the IPC in maintaining and updating the Tukul folders
iii. Administrative support to translation when needed
iv. 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
5. Logistical support:
- Travel arrangement, hotel booking and logistics support to the 3 QA Coordinators, the ERB Chair and to external experts
- Undertake other duties as required
VI. PROFILE REQUIREMENTS
- Humanitarian interest
- Fluent English and French required (written and oral with very good English writing skills)
- Experienced in database 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 required
- Flexibility, availability to work outside of standard working hours, ability to travel
Starting date: as soon as possible
Contract: open-ended – Full time position
Deadline for application: 3 May 2013
Please submit all applications only by email to: IOemail@example.com stating “Assistant to QA coordinators and ERB Chair” in the title
Only short-listed candidates will be contacted