Senior Pharmacovigilance Manager

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 Overview Provide 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 Requirements Bachelor’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 Have Designing and implementing donor‑funded projects within the pharmaceutical sector Engaging with global pharmaceutical stakeholders and contributing to international regulatory systems agendas and programs Pharmacovigilance systems, including risk management, signal detection, and adverse event reporting Regulatory system strengthening activities including market authorization, governance and policy, market surveillance, with an emphasis on pharmacovigilance International regulatory standards and guidelines, including ICH, WHO, and GxP Pharmacovigilance Additional Information Telecommuting 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 View email address on click.appcast.io and reference MD0031. Supervisory Responsibilities None, this is an individual contributor role. Work Hours and Compensation 40 hrs/week, Mon‑Fri, 8:30 a.m.–5:30 p.m. Salary: $183,414/yr. Standard company benefits. Equal Opportunity Employer Equal 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 Category Technical Programs Job Type Full‑Time #J-18808-Ljbffr US Pharmacopeia