The U.S. Pharmacopeial Convention (USP) Senior Pharmacovigilance Manager in Rockville, Maryland
Summary of the Position
The Senior Pharmacovigilance Manager is responsible for the development and implementation of the USP Global Health strategy on pharmacovigilance (PV). The individual provides oversight for all pharmacovigilance related activities, strategies and technical content. This role is key in organizing and delivering internal technical assistance on pharmacovigilance related topics to GHMS units. The success of this role will be measured through satisfaction of internal stakeholders and demand for the Senior Pharmacovigilance Manager’s services. The role will help expand USP’s role in supporting countries in the regulatory function area and as a thought-leader in the pharmacovigilance space.
The Senior Pharmacovigilance Manager will report to the Senior Director, Global Health Technical Program, and work collaboratively across the GHMS division. The role will also lead PV activities undertaken by all donor funded program, functioning as the accountable point of contact.
Roles and Responsibilities
Technical oversight and thought leadership (55-65%)
Serves as subject matter expert for all donor funded work in pharmacovigilance and may lead in direct implementation of pharmacovigilance interventions
Lead in the development of strategies for building, supporting or strengthening pharmacovigilance systems.
Assess country regulatory frameworks for pharmacovigilance systems and provide technical support to improve policy and practices.
Focal point for regional initiatives to develop and implement good PV practices that include reporting of product quality issues, adverse drug events and medication errors.
Prepare written technical briefs, including country and global updates on technical issues and/or issues of strategic importance.
Design, customize, and conduct training courses on PV-related technical areas for donors, external audiences and staff.
Develops concept notes and tools for the integration of quality and safety surveillance systems.
Manages external technical collaboration with Program for International Drug Monitoring and other relevant groups.
Mentor junior HQ and in-country staff in the area of PV.
Provide technical assistance and support to other relevant regulatory functions.
Business development (20-30%)
Develops relationships with key potential clients, including donors and regulatory authorities
Represents GHMS’s technical leadership in pharmacovigilance at external forums
Works with stakeholders to develop new opportunities and collaborate with Senior Technical Director to follow through on identified leads
Collaborates with internal and external GHMS teams to generate technical thought leadership content
Designs and contributes to writing high-quality technical approaches for proposals in response to EOIs/RFIs/RFAs/RFPs
Product expansion (15%)
Drives strategic thinking in pharmacovigilance and drug safety
Works with Senior Technical Director to follow up and evaluate adjacent opportunities.
BS in public health, biological/physical sciences, pharmaceutical science or closely related field.
Minimum of five (5) years of experience in pharmacovigilance or drug safety.
Demonstrated experience working in international public health systems strengthening with relevant regional and international bodies and associations.
Demonstrated success working effectively leading a multidisciplinary and international project team.
Previous experience working in a medicines regulatory authority.
Demonstrated experience working with the Uppsala Monitoring Centre.
Experience in pharmaceutical services and systems strengthening, including the implementation of prevention, care, and treatment programs in developing countries
Excellent oral, written and presentation skills with ability to present to senior level executives and government representatives.
Ability to travel up to 25%.
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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time