Technical Officer - Post Marketing Surveillance (PMS)
Detailed Job description / requirements:
Position: Technical Officer - Post Marketing Surveillance (PMS)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that 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.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
USP is seeking for a Technical Officer - Post Marketing Surveillance (PMS) in support of PQM+ program implementation in Nepal.
Summary of the Position
Under the direct supervision of Technical Advisor QA/QC the Technical Officer Post Marketing Surveillance (TO-PMS) will support National Medicines Regulatory Authorities (NMRA) i.e., Department of Drug Administration (DDA), National Medicine Laboratory (NML) and to strengthen the market surveillance and control function of NMRA at national and subnational levels. S/He will collaborate with NMRA (DDA/NML), National Programs, Logistics Management section, relevant departments of Ministry of Health and Population and other public/private sector stakeholders to ensure the timely and quality implementation of PQM+ program supported interventions at national and sub national Levels. S/he will assist the Technical Advisor QA/QC in day to day management, reporting and any other assigned tasks to meet the program requirements. This is a non-supervisory, individual contributing position responsible for the on-site day-to-day activities at Department of Drug Administration.
Roles and Responsibilities
1. Planning, Coordination and Management:
- Coordinate with the officials of Planning, Coordination and Management Division of DDA and Technical Advisor QA/QC to facilitate various processes regarding PMS activities as per work plan.
- Facilitate PQM+ activities at DDA and NML. For example: assisting the technical advisor in field visits for RB-PMS activities, drafting reports, coordinating with officials, preparing meeting minutes, drafting required documents etc.
2. Document Review, Designing and Endorsement:
- Support the planning, coordination, and management division to draft/ revise various technical and management documents for RB-PMS, like Standard Operating Procedures, Information management Forms and formats, RB-PMS reports etc.
- Assist to organize and facilitate trainings, meetings (like documentation, communication and so on)
3. Capacity Building, Data Management and Reporting
- Assist in technical QA/QC implementation of PQM+ by helping in preparation and management of trainings at the PMS section of DDA.
4. Program Support:
- Help the Technical Advisor QA/QC to give updates on the PMS activities in monthly/ quarterly/ annual reports; and to prepare the annual work plan.
- Assist Technical Advisor QAQC on program related activities, when and where required.
- Masters of Pharmacy
- Minimum of five (5) years of experience in the Pharmaceutical Quality Assurance.
- Experience in working with medicine regulatory authority in Nepal.
- Experience in community/hospital pharmacy or in supply-chain of pharmaceuticals.
- M. Pharm or equivalent.
- Prior experience in USAID project
- Prior experience in post-marketing surveillance.
- Good knowledge of Microsoft Word and Excel operations
- Excellent client relationship management skills
- Excellent written and verbal communication skills
- Ability to work in cross-cultural settings.
- Ability to demonstrate highest degree of ethics and integrity.
Interested candidates should submit cover letter and CV by email to GPHNepalRecruitment@USP.org clearly stating Technical Officer - Post Marketing Surveillance (PMS) in the subject line of the e-mail.
Application Deadline: September 4, 2022