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Médecins sans frontières recrute 01 Pharmacien Affaires Réglementaires



Médecins sans frontières recrute 01 Pharmacien Affaires Réglementaires H/F

Description 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.Médecins Sans Frontières Logistique (MSF Logistics) is a French Association (1901 Law) non lucrative. MSF logistics is a Humanitarian European Supply Centre (ESC) created by MSF France in 1986.

Based in Merignac (Bordeaux City- France) with a hub in Dubai, this ESC has the mission to supply – in drugs, medical consumable, technical equipment, vehicles and diverse equipment – the humanitarians projects deployed around the world.

The services offered by MSF logistic encompasses the entire supply chain management purchase, supply, storage, kits assembly plant, order management and transport organization.

Context & Organisation

MSF’s pharmacist network has as a key objective to assure the quality and availability of pharmaceuticals used in MSF projects. An international qualification scheme for Pharmaceuticals/ Medical Devices (MD) and Therapeutic Foods has been established and is implemented under the coordination of MSF International Pharmaceutical, Medical Device and Therapeutic Food Coordinators. MSF’s ability to continue to import medical supplies into project countries is essential for the continuation and medical quality of its operations.

MSF is facing increased operational challenges regarding importation constraints in countries where the organisation is working. The increased stringency of National Medicines/MD Regulatory Authorities (NMRA) concerning regulation of Medical products in the settings where MSF is working requires a harmonised approach between MSF Operational Centres (OCs) and European Supply Centres (ESCs) with improved coordination and communication. Clear country-by-country instructions need to be provided to the three MSF ESCs in order that appropriate regulatory documentation can be centralised and readily accessed, avoiding process duplication and promoting a more pro-active response to this issue including informing product sourcing decisions. In addition, MSF ESCs face an increasing no. of requests from suppliers linked to country-specific supply restrictions, highlighting the need for a comprehensive and coordinated MSF approach to addressing medical product procurement requirements in order to ensure an efficient service delivery by ESCs. The Regulatory Affairs Pharmacist position was therefore created in 2015 to help ESC address these challenges.

The MSF Pharmacist Regulatory Affairs works directly with the European Supply Centres (ESCs) and ensures a close collaboration with the ESC Pharmacists and Intersectional (ISP)/ Section Pharmacists (SP) and Supply colleagues with respect to defining import requirements for Medical products (Pharmaceuticals, Medical Material and Therapeutic Food).

 

Objectives & responsibilities

The key objectives of the position are :

 

  • To work as a regulatory affairs focal point for MSF, supporting ESC to develop and maintain an intersectional structure to review and validate country importation requirements for medical products
  • Maintenance of inter-ESC document repository for non-batch related regulatory documents and country-specific import information (in collaboration with Pakistan ISP)
  • Identify priority product validations related to import constraints requirements for which a supply solution has not been identified and follow-up with ESCs/IO to find a solution or therapeutic alternative in order to secure supply for medically critical products.
  • Provide technical support to Section Pharmacists and MSF Missions regarding import constraints and lobbying approach with authorities/external actors

 

Your main duties :

  • Maintenance of Oodrive ESC (document repository including Admin. Responsibilities
  • Develop (in collaboration with ISP where applicable) and maintain a concise “Fiche Pays”/ Country Constraints sheet for the problematic focus countries as requested by the 3 ESCs
  • Liaise with IO Intl Medical Device Coordinator in order to link the storage/access needs for non-batch related Medical Device documentation collected as part of QA product validation to the needs of import constraints countries

 

  • Contribute to Pharma network collaboration with MSF Legal Dept. regarding country import requirements and use of legal tools such as Memorandum of Understanding (MoU) and Host Country Agreement (HCA) to support importation requirements for medical products.
  • Support Pharma-Supply trainings on Regulatory Affairs topic to increase awareness and help build MSF field and operational capacity to respond to regulatory challenges.
  • Support Section Pharmacist/mission in defining/negotiating importation requirements where applicable; upon request provide a direct Operational support (country level visit) to negotiate with NMRA their importation requests
  • Coordinate responses between the concerned OCs and ESCs when new/change requests from countries arise and act as ESC focal point regarding validation of information and appropriate response (ensuring any resultant change in process is clearly communicated at Ops/Esc and mission level). This should include consideration of demands received via external clients (re MSF Log and Supply) to ensure where MSF is operational in same country there is a consistent approach i.e. ESC is not providing documentation to external client that is NOT required for MSF to import in same country
  • Support ESC and MSF Access Campaign Pharmacists with regards to lobbying/ defining import requirements for specific countries or new medicines, especially in framework of ESC pooled procurement (ARV,HCV,TB, Malaria, DINF and DVAC products plus certain families of Medical Material )
  • Identify priority product validations related to import constraints for which a supply solution has not been identified and follow-up with ESCs/IO to find a solution or therapeutic alternative to enable supply to be maintained for critical products to problematic countries. Includes participation in monthly PRIO List (IO and ESC) platform and support to ITC re review of annual Summary of Changes
  • On-going monitoring of regulatory environment (country and international levels) in collaboration with CAME order to inform Pharmacist Network and Ops as part of a pro-active approach to import constraints

 

Ville Paris
Expériences / Formation du candidat Genuine interest in, understanding of, and commitment to MSF’s humanitarian charter and the principles concerning quality assurance of medicines and implementation of MSF Medical Procurement Policy 

Qualifications and work experience :

  • Pharmacy degree
  • Strong interest and experience working with quality assurance for medicines and regulatory affairs topic.
  • Minimum 3 years professional experience, including some field pharmacist experience in developing countries with MSF or another similar organisation
  • Knowledge of, or experience with, importation constraints at country level in MSF operational contexts a distinct advantage
  • Experience with pharmaceutical quality assurance and medical supply/procurement is an asset

 

Particularities :

  • Oral and written fluency in English mandatory and French an added advantage
  • Mature with strong interpersonal skills and the ability to interact diplomatically at all levels within MSF
  • Excellent organisational skills with a strong practical focus
  • Strong analytical and problem-solving skills combined with attention to detail are a priority to be effective in this role
  • Self-driven & pro-active with the ability to work and report independently
  • Willingness to travel regularly in Europe and on request to MSF mission countries
  • Able to represent MSF externally and adapted to cultural context of MSF missions
Experience 5 à 10 ans
Fonctions Autre
Secteurs d’activité Santé
Pays Europe, France
Salaire / Indemnité Starting date : no later than December 1st 2019Contract : Permanent contract

Location : MSF Logistique – Mérignac (33700) France, Brussels or Amsterdam with regular travel to other ESCs

Monthly Salary : 3729€ bruts per month over 13 months

Comment postuler Application (CV + cover letter) with the reference « 2019-10 Pharmacist_RA » to be send before November 3rd, 2019 directly on our website:https://www.msflogistique.org/msf-logistique-job.html

 

Applications containing only CVs will not be considered. If we do not reply within 3 weeks of the closing date for applications, please consider that your application has not been accepted.

Postuler en ligne https://www.msflogistique.org/msf-logistique-job.html
Date de fin de validité 03/11/2019[

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