Job Title: Back-up Pharmacist/ Assistant Regulatory Affairs Manager(P/RAM).
Makerere University Walter Reed Project - Kampala, Central Region, Uganda
Job Description
JOB SUMMARY: The incumbent will serve to back-up the full-time Pharmacist/RAM for the Makerere University / Walter Reed Project (MU/WRP) located at Plot 42 Nakasero Road. The individual will serve under the immediate supervision of the Pharmacist.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Importation, Maintenance, Inventory, Preparation, Dispensing and Disposal of Investigational and non-Investigational Drugs
• Pharmaceutical supplies management of ARVs for the PEPFAR program
• Pharmaceutical supplies management of OI drugs and other medications for MUWRP Cohorts and PEPFAR programs.
• Compliance with clinical research study procedures and GCP standards
• Ensure research participant safety and confi dentiality.
• Writing, Revising and implementing Standard Operating Procedures.
• Liaison with USMHRP Clinical Trial Specialists, local and external IRBs, Regulatory Authorities and Sponsor representatives
• Preparation of clinical research regulatory submissions including initial, continuing review reports, SAEs, deviations, final study reports and communications to local IRB, National Drug Authority, and Sponsors
• Coordinate site monitoring visits with Principal Investigator and sponsors
• Maintain Essential and other regulatory documents as pertinent to Clinical research to include 1572, curriculum vitae, study specific SOPs, etc and IRB approved versions of protocols, informed consents and supporting documents including translations.
ESSENTIAL FUNCTIONS:
• Highly organized, detail-oriented and self-motivated.
• Ability to handle multiple tasks simultaneously.
• Ability to work on own initiative.
• Ability to professionally communicate in writing, verbally or other means deemed appropriate.
QUALIFICATIONS:
• Bachelor’s degree in Pharmacy
• Minimum of 2 years of post-qualifi cation professional experience.
• Strong leadership and communication skills.
• Good interpersonal/communication skills
• Fluency in verbal and written English and at least one local language.
EXPERIENCE/EDUCATION/TRAINING:
1. Good Clinical Practice (GCP) training.
2. Research Ethics Training
3. A basic knowledge of Clinical Research Regulatory Procedures.
4. Use of basic computer software to include word processing,
spreadsheets, power-point, email and Internet.
PHYSICAL ABILITY: The ability to travel within work sites in
Kampala and upcountry field stations.
How to Apply
The Makerere University Walter Reed Project (MUWRP) is a non- governmental, non- profit HIV research program that was established in 2002 as a result of a memorandum of understanding between Makerere University and The Henry M. Jackson foundation for Advancement of Military Medicine Inc. of USA (HJF). The primary purpose of MUWRP is to develop, evaluate and provide interventions to mitigate disease threats of public health importance to Uganda. Activities include; vaccine development and building of vaccine testing capability in Uganda, conducting of epidemiological and basic research and provision of HIV Treatment, care and support and surveillance of influenza and other emerging infections. The Project is looking for a suitable candidate to fill the position above;
Interested candidates should send their Applications, relevant photocopies of academic qualifications and Resume with 3 referees to:
The Human Resource Administrator
Makerere University Walter Reed Project
Plot 42 Nakasero Road.
P.O. Box 16524 Kampala.
Only shortlisted candidates will be contacted.
Deadline: 30th Jan 2013
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