Technical Advisor - Regional PQM+U.S. Pharmacopeial Convention (USP)

• The Promoting the Quality of Medicines Plus (PQM+) program is funded by the U.S. Agency for International Development (USAID) and is implemented by the United States Pharmacopeial Convention (USP) to sustainably strengthen medical product quality assurance (QA) systems in low- and middle-income countries (LMICs).
• Note: This role will serve as a Regional team member in Nigeria (other alternative locations include Kenya, Ethiopia, Senegal, Ghana, or Rockville in the US)

How will YOU build impact here at USP?

• As a member of the PQM+ technical team, the Technical Advisor provides support to countries for the scale-up of their quality and safety surveillance and monitoring programs. S/He closely collaborates with Medicines Regulatory Authorities (MRAs) and National Immunization Programs (NIPs) to strengthen their capacities in pharmacovigilance (PV) and for detecting, investigating, and analyzing adverse events following immunization (AEFIs) and that of special interest (AES); and for ensuring their appropriate and rapid response. With the roll-out of the COVID-19 vaccine, PQM+ Technical Advisor will specifically support local partners in target countries to strengthen their post-authorization or post-approval quality and safety surveillance programs, both at the national and regional levels. The incumbent reports to the PQM+ Senior Technical Advisor RSS at HQ and collaborates closely with other HQ Senior and Technical Advisors for marketing authorization (MA), post-marketing quality surveillance (PMS), and Medical Devices, as well as with regional and country teams to ensure synergy in program delivery and consistency of technical approaches.

Roles and Responsibilities

• Assess national PV/Vigilance systems with a special focus on the quality and safety of biological products, including vaccines and medical devices. Attention is given to surveillance policy, legal framework, rules and regulations, guidelines, and practices as well as the coordination mechanisms between the MRA and NIP on AEFI, AESI, and product quality matters related to vaccines
• Provide technical input in the development of national and/or regional plans for PV/VL and AEFI and AESI surveillance
• Guide MRAs in performing effectiveness and safety complaint investigations and in meeting the requirements of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as well as the U.S.FDA’s Center for Devices and Radiological Health (CDRH) regulation and guidelines
• Guide MRAs in the adoption of international standards, guidelines, and tools for pharmacovigilance; also provide support to MRAs in adopting data standards such as Medical Dictionary for Regulatory Activities (MedDRA), WHO Adverse Reactions Terminology (WHOART), and Individual Case Safety Reports (ICSRs)
• Provide technical input in the implementation of active safety surveillance programs for COVID-19 vaccines and help establish coordination mechanisms between communicable diseases control programs and MRAs.
• Prepare and conduct training programs for health care workers and local partners focusing on identification and reporting of PV for medicines and AEFI for vaccines
• Support the review and the adaptation of processes for timely reporting, reviewing and data sharing nationally, regionally, and globally e.g., to Uppsala Monitoring Center (UMC).
• Provide technical input in the development of standard operating procedures (SOPs) for the coordination between MRAs, NIPs, and other institutions with responsibilities for PV and AEFI surveillance.
• Develop scope of work (SOW) and set up AEFI committees at the national level
• Prepare investigation teams and train them on AEFI investigation activities that are relevant to the population being vaccinated.
• Train members of the National AEFI committee on causality assessment processes using WHO causality assessment guidelines.
• Work closely with the Sr. Technical Advisor, RSS to ensure that the program’s technical approach for vaccines safety surveillance and medical devices effectiveness and safety monitoring is integrated within the program’s offerings
• Support documentation of lessons learned best practices and technical approaches and support program reporting activities; also maintain current knowledge of trends and innovations related to quality and safety surveillance for vaccines and medical devices
• Conduct other tasks related to strengthening systems for pharmacovigilance and vaccine safety as assigned

Who USP is Looking For?
The successful candidate will have a shown understanding of our mission, commitment to excellence through diverse and equitable behaviors and practices, and ability to quickly build credibility with collaborators, along with the following competencies and experience:

• Bachelor’s Degree in Pharmacy, Clinical Pharmacology, or relevant field.
• Eight (8) years experience in regulatory systems strengthening, especially related to pharmacovigilance, safety surveillance, clinical pharmacy, and/or pharmaceutical regulation
• Solid knowledge and understanding of the guidelines, SOPs, national and international norms, and practices of PV systems, especially in Africa
• Knowledge of adverse trends and events reporting

Additional Desired Preferences:

• A Master’s Degree in Pharmacy, Clinical Pharmacology, or related field or a PharmD or in Clinical Pharmacy
• Demonstrated hands-on experience in assessing gaps, developing plans, and strengthening PV systems in Africa, Asia, or any other region.
• Hand-on experience in providing support in:
• Developing capacity building of Pharmacovigilance centers and managing its operations
• Developing training materials and courses, seminars, workshops, etc.
• Deployment of tools and guidelines for pharmacovigilance implementation
• Sensitizing and raising public awareness of pharmacovigilance
• Direct experience and understanding of the WHO Global Benchmarking Tool, especially the vigilance function
• Demonstrated experience in supporting clients with quality management systems for ISO 13485 - medical device regulation, post-market surveillance, and quality assurance
• Familiar with Risk Management (ISO 14971) activities including risk assessments and PMS/PV/VL surveillance technical and regulatory requirements.

Benefits
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being are protected.