Home Pharmacy practice Pharmacy manager – endTB project M/F – France

Pharmacy manager – endTB project M/F – France

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endTB is a project that aims to provide access to new treatments for patients with multidrug-resistant tuberculosis (MDR-TB). The project is carried out in partnership with Partners in Health (PIH), Interactive Research and Development (IRD), Harvard Medical School (HMS), Institute of Tropical Medicine-Antwerp (ITM), Epicenter 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 underway:

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

Both are carried out under the responsibility of MSF France as Sponsor in 11 sites spread over 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, made up of around fifteen people, divided between the various partners, some of whom are based in Paris.

Context and objectives

Responsibilities for pharmaceutical activities are divided between several levels.

At the national level, study site pharmacists are responsible for the daily supply of patient medications in accordance with ICH standards for clinical trials.

At the Promoter/Central level, the Clinical Trial Pharmacist mainly assists the sites to ensure optimal management of stocks of trial drugs (Investigational Medicinal Products (IMPs) and non-IMPs) and other medical supplies, in troubleshooting problems that arise. pose; monitors consumption and expiration of trial drugs at all trial sites; ensures that orders are placed in a timely manner; visits trial sites to ensure compliance with endTB Standard Operating Procedures (SOPs) for pharmaceutical management and to train new staff joining the pharmacy trial teams; and ensures that the trial complies with all applicable regulatory requirements relating to the manufacture, handling and storage of IMPs.

Medicines are mainly supplied through MSF Logistique, for MSF and non-MSF sites.

The level of activity at the Promoter/Central level is currently significant due to the high number of patients under follow-up or in recruitment and the large stock of associated drugs, supply activities still in progress, the recent opening of additional sites , the need to anticipate the destruction of drugs before the closure of certain sites in 2023, the current increase in site supervision visits (which could not take place during the COVID-19 pandemic) and business as usual monitoring and Q/A of the pharmacy.

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

Main responsibilities

Under the supervision of the Clinical Trial Manager (from the Sponsor level), you will work closely with the Clinical Trial Pharmacist, the 3 Central Study Coordinators in charge of monitoring the countries, certain Site Pharmacists and the Site Study Coordinators of partner organizations (MSF, PIH, IRD, UCSF) and the central MSF team.

Job requirements

Live:

3 years of experience in drug supply and management – essential.

Experience in multi-site GCP compliant clinical trials – a strong asset.

Experience working in or with resource constrained health systems – an asset.

Education:

Licensed Pharmacist with a Pharmacy degree or higher – essential.

Clinical trial training – essential.

GCP certification – a major asset.

Knowledge and skills:

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

Strong organizational and planning skills and networking experience.

Respect of deadlines and adaptable.

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

Proven experience working independently with minimal supervision.

Ability to work with teams in different locations.

Proven skills to work with Office.

Languages ​​:

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

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

Specifics of the position

Status: 5 month contract (CDD), full time position.

Based in Paris, metro Jaurès.

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

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

How to register

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

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

Only candidates whose applications have been selected will be contacted.