Consultant - Post Marketing Surveillance (PMS) TB Medicine
Job Description
Title: Consultant - Post Marketing Surveillance (PMS) TB Medicine
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Anywhere in Bangladesh
Employment Status: Full-time, Contractual
Educational Requirements:
∎ Preferably a Pharmacy graduate
Experience Requirements:
∎ At least 6 year(s)
Job Context:
∎ Full time consultant for 6 months
∎ Time period between May 2021 - October 2021
Job Responsibilities:
∎ Provide technical assistance to Local Public manufacturers (SOE-EDCL) to produce first line anti-TB medicines to progress towards achieving WHO-PQ
∎ Provide technical assistance to private manufacturer to accomplish Bioavailable/ Bioequivalence (BA/BE) study of first line anti TB medicines.
∎ Provide support to DGDA & NCL to implement RB-PMS of TB medicine
∎ Rapid assessment on SF TB medicine
∎ Finalize RB-PMS plan for TB medicines in consultation with DGDA, NCL and divisional PMS site offices.
∎ Map NQCL needs for carrying out testing of TB medicines.
∎ Work with NCL to develop protocol for testing TB medicines.
∎ Report of lab needs to carry out testing of TB medicines.
∎ Submission of a final report at the end of this consultancy to include in an Annex a full contact list of stakeholders with name, title, phone, email.
∎ Work with PQM+ to select third part to conduct 'Rapid assessment of sources, availability, and quality of first line TB medicines in eight Sadar/HQ districts of eight (08) divisions of Bangladesh'.
∎ Follow-up select third party to conduct assessment as per TOR.
∎ Follow-up third party to Complete the assessment on time.
∎ Arrange meetings time to time with the PQM+ team and the select third party to ensure progress and to solve issues.
∎ Ensure quality of assessment at all stages of conduction.
∎ Ensure submission of assessment report on time.
∎ Submit weekly, by weekly and monthly progress reports to USP PQM+ program & USAID.
∎ Any other activities are assigned by PQM+ Management.
∎ Sampling and testing protocol for TB medicines.
∎ RB-PMS Report
∎ Requirement analysis of Minilab supplies (reference standard, reagent, chemicals, lab coat, PPE items accessories, etc.) and ensure to supply.
∎ Assessment report of SF TB medicine
∎ Monthly activities reports instead.
Additional Requirements:
∎ Minimum 6 (six) years of working experience
∎ Good understanding about function of medical regulatory authorities (MRAs) to ensure the quality and availability of medical products including vaccine.
∎ Understanding /experience in working in the field of regulatory affairs
∎ Understanding /experience in working in QC laboratory
∎ Demonstrated direct experience implementing USAID-funded programs
∎ Good understanding of medicine quality testing and field level surveillance.
∎ Experience in technical report writing, SOP development, and knowledge of global health development donors, including USAID, CDC, and other multilateral donors and foundations
∎ Practical experience in implementing research project is an additional advantage
∎ Good understanding about DGDA (NCL) drug testing laboratory
∎ Understanding and working experience with WHO, INGOs, Govt. agencies that are implementing regulatory system and laboratory system strengthening programs.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 22 May 2021
Company Information:
∎ 17 May 2021
∎ U.S. Pharmacopeial Convention
∎ Business : The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization founded in 1820. It sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP?s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Category: Medical/Pharma
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