Who is USP?The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high‑quality medicines worldwide.Brief Job OverviewProvide technical oversight and implementation on donor-funded projects related to Pharmacovigilance (PV) and adjacent Regulatory Services Strengthening (RSS) activities. Work with NRAs and regional regulatory agencies to strengthen the PV Legal Framework and Guidelines. Assess and identify gaps in PV legal frameworks of NRAs and Regional Ethics Committees (RECs). Develop and advocate for new laws, directives, regulations, policies, and guidelines consistent with international standards. Facilitate regional approaches to safety surveillance using mutually agreed and recognized guidelines. Support developing proposals involving PV and some related RSS activities. Support new business development opportunities that relate to RSS. Identify, review, develop, and continuously improve technical approaches to Global Health and Manufacturing Services (GHMS) core areas. Identify new and adjacent areas in PV and RSS for GHMS to contribute by identifying needs, developing plans. Support donor engagement/prime engagement. Support the onboarding of new staff who need technical orientation.Minimum RequirementsBachelor's degree or foreign equivalent degree in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Public Health, Global Health, Medical Sciences, or a related field, and seven (7) years of post‑bachelor's, progressive, related work experience.Must HaveDesigning and implementing donor‑funded projects within the pharmaceutical sectorEngaging with global pharmaceutical stakeholders and contributing to international regulatory systems agendas and programsPharmacovigilance systems, including risk management, signal detection, and adverse event reportingRegulatory system strengthening activities including market authorization, governance and policy, market surveillance, with an emphasis on pharmacovigilanceInternational regulatory standards and guidelines, including ICH, WHO, and GxPPharmacovigilanceAdditional InformationTelecommuting permitted on a hybrid schedule as determined by the employer. Up to 25% domestic or international travel required. To apply, please email resume to Sundar Nagarajan at Sundar.Nagarajan@usp.org and reference MD0031.Supervisory ResponsibilitiesNone, this is an individual contributor role.Work Hours and Compensation40 hrs/week, Mon‑Fri, 8:30 a.m.–5:30 p.m. Salary: $183,414/yr. Standard company benefits.Equal Opportunity EmployerEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.Job CategoryTechnical ProgramsJob TypeFull‑Time#J-18808-Ljbffr
| Location | Rockville, MD |