Pharmacy Officer– endTB project M/F

  • Contractor
  • Paris France
  • TBD USD / Year
  • Médecins Sans Frontières profile




  • Job applications may no longer being accepted for this opportunity.


Médecins Sans Frontières

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.

Context and objectives

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.

Main responsibilities

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.

Job requirements

Experience:

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.

Education:

Registered Pharmacist with a pharmacy degree or higher – essential.

Training in clinical trials – essential.

GCP certification – a strong asset.

Knowledge and skills:

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

Strong organization and planning skills and experience in networking.

Deadline-adherent and adaptable.

Excellent interpersonal skills and a proven ability to gain buy-in and commitment from a range of people.

Proven experience of working independently under minimal supervision.

Ability to work with teams in different locations.

Proven skills to work with Office.

Languages:

Fluently spoken and written English (work mainly in English) – essential.

Good level of French (occasional work in French with some interlocutors) – an asset.

Specificities of the position

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: ASAP, early Sept 2022.

How to apply

Please send your application (cover letter and CV in English, mentioning your availability date) until August 7th 2022 included.

to https://www.msf.fr/agir/rejoindre-nos-equipes/toutes-nos-offres-emploi/pharmacy-officer-endtb-project-mw

Only the candidates whose applications have been selected will be contacted.


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