USP - PQM+ Pakistan team would like to hire an International Consultant who will provide regulatory support to DRAP for development of BE policy, roadmap for phase wise implementation of BE studies and capacity building programs. Under the overall direction of PQM+ Chief of Party the entity/Individual will:
1. Desk review of international BE Policies and regulations
2. Consultative meeting with stakeholder to have an overview current policy, procedures, and their capacities.
3. Prepare a Draft National BE Policy
4. Hold Consultative meetings with DRAP and stakeholders on National BE Policy
5. Provide technical assistance to DRAP for required changes in national regulations for implementation of BE Policy
6. Draft a list of Priority Molecules and roadmap for phase wise implementation of BE Studies,
7. Support DRAP for strategy development to implement BE Policy
8. Training of DRAP Staff on data analysis and data interpretations
9. Training of DRAP staff on Evaluation of BE Study Reports, including technical support to DRAP to review the process of evaluation of study reports and suggestions on the competency of BE studies reviewers to enable fast and fair assessment of bioequivalence testing studies submitted as part of product registration to DRAP.
10. Develop a roadmap and performance monitoring mechanism for ensuring high-performance compliance of bioequivalence (biostudies)/DRAP staff
1. Consultative meetings report
2. Draft National BE Policy
3. Roadmap for phase wise implementation of BE Studies
4. Training materials
5. Training report
1. At least a Master’s degree in Pharmaceutical Sciences.
2. At least Twenty years’ experience in pharmacokinetics or biopharmaceutics or bioequivalence testing.
3. International Proven Experience with Reference Authorities.
4. Hands-on experience and work understanding of pharmacokinetics and/or bioequivalence studies.
5. Demonstrated ability in developing policies, regulations, and guidelines related to biopharmaceutics or pharmacokinetics or related field.
6. Demonstrated ability to lead professionals and manage others through influence and collaboration.
7. Demonstrated ability to conduct and interpret quantitative/qualitative information with analytical problem-solving.
8. Proven leadership skills in consulting with demonstrated experience in training and mentoring staff and others.
9. Excellent oral and written communication skills in English; knowledge of the local language is desired.
10. Must demonstrate an understanding of the operations, health policy trends, and any applicable regulations related to the responsible technical area.
PERIOD OF PERFORMANCE
The scope of the work defined herein level of efforts required for the assignment will be for 25 Working Days Level of Effort (LOE) from the date of the sign of the contract.
Selected firm/ individual will develop and work remotely in consultation with the USP Pakistan team and DRAP team.
Selected firm/ individual will report to the PQM+ Chief of Party.
1. Past Experience - 40%
2. Qualification and Education - 35%
3. Financial Proposal- 25%
Please be sure to indicate that you saw this position on Globaljobs.org