[e-drug] MSF looks for a Senior Pharmacist full time in Geneva (full TOR)

[Fernando.PASCUAL@geneva.msf.org]

E-DRUG:MSF looks for a Senior Pharmacist full time in Geneva (full TOR)
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{to respond DO NOT CLICK REPLY.  Resond to Isabelle.Saussereau@geneva.msf.org ]

Job Title: Senior Pharmacist for regulatory and quality issues
   Campaign for Access to Essential Medicines, MÃdecins Sans FrontiÃres
                  http://www.accessmed.msf.org/index.asp

                     Job location: Geneva, Switzerland
            Salary: depending on Professional experience/level
                  Start date:  ASAP (preferred June 2007)

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ABOUT THE ACCESS CAMPAIGN
The  Campaign  for  Access  to  Essential  medicines  MSF  Campaign  is  an
international  MSF  project.  It was launched in 1999 after a reflection on
the quality of medical care dispensed by MSF.  General objectives are:
1.       To make new 'life-saving or essential' medicines, vaccines and
diagnosis tools affordable and accessible, in particular focusing on
patents as one of the main access barriers that causes high prices,
2.       To secure the production and accessibility of quality essential
medicines, vaccines and diagnosis tools that have either been abandoned, or
for which stock discontinuation is leading to access problems.
3.       To stimulate research and development activities of new medicines,
vaccines and diagnosis tools for neglected diseases

In  addition,  a  key  function  of  the  MSF  Campaign is to challenge and
stimulate  MSF  to  not  accept  a status quo based on sub-standard medical
tools,  and  to  contribute  to  the position of MSF concerning quality. In
particular,  the  MSF Campaign wants to get more involved on quality issues
from two points of view: quality problems from a end-user point of view and
quality standards from an access point of view. The first implies analyzing
the  problem  of  substandard  and  counterfeit  drugs  an  its  impact  in
developing  countries.  The  latter  implies  better  understanding quality
standards.

More information can be found on www.accessmed-msf.org

THE PLACE OF MSF ACCESS CAMPAIGN IN MSF PHARMACEUTICAL NETWORK
MSF  Access Campaign pharmacist team is also part of to a larger network of
pharmacists  in  MSF,  consisting  of  Procurement Centers Pharmacists, and
Section  Pharmacists  who are all in charge of the procurement of drugs for
MSF   projects.   This   network   is   coordinated  by  the  International
Pharmaceutical Coordinator (IPC).

JOB GENERAL OBJECTIVES
Placed in the MSF Campaign pharmacist team (3-4 pharmacists), this position
is   in  charge  of  questions  related  to  quality  and  safety  for  new
formulations/products  as  well  as  regulatory  issues. He/she is also the
Campaign  link  with  the  pharmacist  network,  and  particularly with the
international coordination for quality issues.

MAIN DUTIES AND RESPONSIBILITIES
Strategy planning:
Participate  in  strategies  definition  and  planning  to  overcome access
problems,  mainly  related  to  quality,  regulatory  issues  and  lack  of
development  and adaptation to the field, affecting medicines. This will be
done  in  close relation with the pharmaceutical international coordination
Thanks  to  this  link  with  the  coordination,  the senior pharmacist for
regulatory  and quality affairs will assist the MSF Campaign Pharmaceutical
coordinator on setting priorities.

MSF Campaign Focal point for regulatory issues:
-  Develop MSF Campaign strategy on regulatory issues related to R&D in
cooperation with other team members
-  Analyze regulatory barriers to importation and propose strategies
-  Provide strategic input on regulatory issues related to off-label use of
drugs, compassionate use, fast-track registration, regulatory requirements
for changes in dose of already approved products.
-  Focal point for clinical trials conducted in MSF-Epicentre in relation
with pharmaceutical issues.

MSF Campaign Focal point for quality and safety:
-  Analyze access barriers related to quality of APIs and finished products
(standards applied for quality and safety, missing standards, regulatory
requirements, existing monographiesâ), in coordination with IPC.
-  Participation on discussions with institutions in charge of the
definition of norms and standards: EMEA, FDA, WHO, ICDRA, ICH, PIC/S
-  Focal point person with organizations dealing with procurement in order
to collect and analyze access barriers related to quality or efficacy:
UNICEF, ICRC, GF, Global Fund, WHO Procurement Departments, Clinton
Foundation
-  He/she will also collaborate with WHO, ICH - on the definition of quality
specifications better adapted to developing countries conditions.
-  Focal point with companies, both originator and generics, on quality and
safety issues for new formulations/products.

MSF Campaign focal point for Sub-standards and counterfeits medicines:
-  Follow-up of the reality of pharmaceutical markets in several pilot
countries in coordination with section pharmacists, with specific follow-up
on sub-standards and counterfeits (i.e. Artesunate in South East Asia).
-  He/she will also contribute to elaborate MSF message on quality of drugs
in developing countries.

Documenting of Pharmaceutical companies pipeline:
Together with Campaign Medical Director and R&D Coordinator:
-  Contribute to identification of interesting products in the pipelines of
companies, analysis of what is required for approval and WHO PQ and
potential involvement of MSF in this research.
-  Together with Campaign R&D coordinator and Campaign medical director,
link with Medical Departments and Epicentre to bring pharmaceutical
Campaign priorities to operational research agenda when needed.
-  Focal point on pharmaceutical issues with institutions dealing with R &
D (DNDI, TDR -).


ACCOUNTABILITY:
-  Accountable to CAME Campaign Pharmacist Coordinator
-  In close contact with Campaign Medical Director, Campaign R&D
Coordinator and MSF International Pharmaceutical Coordination

MAIN COUNTERPARTS OUTSIDE THE CAME:
Pharmacist  network,  specially  the  disease  focused pharmacist position,
International Pharmaceutical Coordinator, Epicentre, Medical Departments

ESSENTIAL REQUIREMENTS
  Pharmaceutical diploma with at least 10 years post graduate experience
mainly on regulatory affairs and clinical studies
  Proven experience of working independently under minimal supervision
  Demonstrable experience of working as part of a multi-cultural team
  Fluency in written and oral English
  Ability to travel

DESIRABLE REQUIREMENTS
  Experience in Pharmaceutical Industry or Drug regulatory Authorities,
particularly, it will be desirable experience on R&D regulatory aspects
  Experience in Advocacy campaigns
  Field experience in at least 2-3 MSF missions or a similar medical NGO
  French and/or Spanish appreciated

    The position is for a minimum period of 12 months, to be reviewed.
            To apply please send your CV and covering letter to
Isabelle.Saussereau@geneva.msf.org by May 6th. Only short listed candidates
                            will be contacted.

Fernando Pascual MartÃnez
MSF Campaign for Access to Essential Medicines
Fernando.PASCUAL@geneva.msf.org