The U.S. Pharmacopeial Convention (USP) Technical Advisor, RSS - Quality & Safety Surveillance of Vaccines and Medical Devices in Rockville, Maryland
Summary of the Position
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) with a goal to sustainably strengthen medical product quality assurance (QA) systems in low- and middle-income countries (LMICs). 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 programs for vaccines and medical devices. 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 (AESIs); and for ensuring their appropriate and rapid response. With the roll-out of 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 level. The incumbent reports to the PQM+ Senior Technical Advisor RSS and collaborates closely with other HQ Technical Advisors for post-marketing quality surveillance (PMS) and for 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 special focus on quality and safety of vaccines and medical devices. Attention is given to surveillance policy, legal framework, rules and regulation, 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.
• Provide guidance to 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, and regional level where applicable.
• 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.
• Lead the implementation of work plan activities related to vaccines safety surveillance and medical devices safety monitoring as well as other regulatory systems strengthening interventions of the PQM+ Program.
• Provide leadership in facilitating LMICs adaptation of international standards and guidelines from the Medical Device Regulators Forum (IMDRF) and World Health Organization (WHO); and their participation in regulatory harmonization and convergence initiatives.
• Maintain current knowledge of trends and new innovations related to quality and safety surveillance for vaccines and medical devices.
• Bachelor’s degree in pharmacy, clinical pharmacology or relevant field.
• Five (5) years’ experience in pharmacovigilance, safety surveillance, clinical pharmacy, and pharmaceutical regulation
• Basic knowledge of ISO 13485:2016 and root cause analysis skills
• Solid knowledge and understanding of the guidelines, SOPs, national and international norms, and practices of PV systems, especially in Africa
• Familiar with Risk Management (ISO 14971:2019) activities including risk assessments and PMS/PV/VL surveillance technical and regulatory requirements.
• Knowledge of adverse trends and events reporting.
• Up to 25% travel
• Eight (8) years’ experience in pharmacovigilance, safety surveillance, clinical pharmacy, and pharmaceutical regulation
• A master’s degree in pharmacy, clinical pharmacology or related field or a PharmD or in Clinical Pharmacy.
• Fluency in French
• Demonstrated experience in developing and strengthening PV in Africa or Asia
• Hand-on experience in providing support in:
developing capacity building in Pharmacovigilance center and manage its operation
developing training materials and courses, seminars, workshops etc.
operationalizing tools and guidelines for pharmacovigilance implementation
sensitizing and raising awareness amongst the public on pharmacovigilance
• Experience in providing technical assistance to LMICs in PV and safety surveillance of vaccines and medical devices.
• 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 13485:2016 - medical device regulation, post-market surveillance and quality assurance.
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
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Job Category Technical Programs
Job Type Full-Time