Pharmacy Officer– endTB project M/W

Médecins Sans Frontières, an international medical humanitarian association created in 1971, provides medical assistance to populations whose lives are threatened: mainly in the event of armed conflicts, but also of epidemics, pandemics, natural disasters, or exclusion from care. The French section of MSF is present in about thirty countries.

In the context of an increase of activity and in order to support pharmaceutical activities on two clinical trials, we are looking for a Pharmacy Officer– endTB project

endTB is a project that aims to provide access to new treatments for patients with multi-drug resistant tuberculosis (MDR-TB). The project is conducted in partnership, with Partners in Health (PIH), Interactive Research and Development (IRD), Harvard Medical School (HMS), Institute of Tropical Medicine-Antwerp (ITM), Epicentre and University of California San Francisco (UCSF). The project is co-funded by Unitaid and some consortium partners.

Two international multicenter randomized therapeutic clinical trials are currently on-going:

• endTB for which the 750 MDR-TB patients are now enrolled, and which will end in 2023,
• endTB-Q for which one third of the 324 XDR-TB patients are still to be enrolled and which will end in 2024.

Both are conducted under the responsibility of MSF France as Sponsor in 11 sites in 6 countries: India (MSF project), Peru, Kazakhstan, Lesotho (PIH projects), Pakistan (IRD project) and Vietnam (UCSF project).

The project is coordinated by a central operational team, including about 15 people, distributed among the various partners, some of whom are based in Paris

Mission

The responsibilities of the pharmaceutical activities are distributed among several levels.

At country level, the study site pharmacists are in charge of the daily provision of drugs to the patients in compliance with ICH standards for clinical trials.

At Sponsor/Central level, the Clinical Trial Pharmacist mainly assists the sites in ensuring optimal stock management of trial drugs (Investigational Medicinal Products (IMPs) and non IMPs) and other medical supplies, in troubleshooting problems that arise; monitors trial drugs consumption and expiry in all trial sites; ensures orders are places in a timely manner; visits trial sites to ensure compliance to endTB Standard Operating Procedures (SOPs) in terms of pharmaceutical management and to train new staff joining the pharmacy trial teams; and ensures that the trial complies with all applicable regulatory requirements pertaining to IMP manufacturing, handling and storage.

Drugs procurement is mainly done through MSF Logistique, for both MSF and non-MSF sites.

The level of activity at Sponsor/Central level is currently important due to the high number of patients under follow-up or recruitment and associated important stock of drugs, the still-on-going procurement activities, the recent opening of additional sites, the need for anticipation of drugs destruction before some sites start closing in 2023, the current increase of on-site supervision visits (that couldn’t take place during the COVID-19 pandemic) and the usual pharmacy monitoring and Q/A activities.

While the Clinical Trial Pharmacist is in charge, the Pharmacy Officer will support this effort with a special focus on drug procurement and drug management, to ensure compliance with the Sponsor obligations and the best possible support to pharmacy activities at site level.

Under the supervision of the Clinical Trial Manager (from Sponsor level), you will work in close connection with the Clinical Trial Pharmacist, the 3 Central Study Coordinators in charge of following up on countries, some Sites Pharmacists and Site Study Coordinators from distinct partner organizations (MSF, PIH, IRD, UCSF) and the MSF central team.

Remote monitoring

• Perform remote monitoring of site pharmacy documents (e.g., stock, accountability logs) to ensure compliance to endTB SOPs.
• Perform remote monitoring of pharmacy documents at the pharmacy on SharePoint (Electronic archiving portal).

Drug procurement

• Assist the Trial Sites in obtaining regulatory approval for drugs importation
• Facilitate custom clearance at Trial Site level when required
• Support the Clinical Trial Pharmacist with reporting on procurement

Drug management

• Assist Site Pharmacists in ensuring optimal stock management of trial drugs (IMPs and non IMPs)
• Support the Clinical Trial Pharmacist for the remote supervision of IMPs destruction at Trial Sites level
• Support the Clinical Trial Pharmacist in troubleshooting problems that arise with storage and excursion reports of IMPs and non IMPs

No on-site supervisions are yet foreseen in the trials’ countries for this position.

This list of activities may be adjusted.

Professional skills

• Registered Pharmacist with a pharmacy degree or higher – essential.
• Training in clinical trials – essential.
• GCP certification – a strong asset.
• 3 years experience in drug procurement and management – essential.
• Experience in GCP-compliant multi-site clinical trials – a strong asset.
• Experience working in or with resource-limited health systems – an asset

Languages: Fluently spoken and written English (work mainly in English) –essential Good level of French (occasional work in French with some interlocutors)-an asset.

Knowledge : ICH-Good Clinical Practice (ICH-GCP), Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP).

Position’s specificities

Status: 5 months contract (CDD), full time position, based in Paris, Jaurès metro station.

Salary conditions: 41.38K€ gross annual salary over 13 months. 22 days RTT/year. Health insurance 100% covered by MSF. Restaurant vouchers with a face value of 9€ (60% paid by MSF). 50% of public transport pass paid.

Desired start date: As soon as possible, during September 2022.