Manager, Pharmacovigilance (US)
About The Position
Worldwide Clinical Trials is hiring a Manager, Pharmacovigilance to lead the delivery of high-quality pharmacovigilance activities supporting the safe development of new therapies across clinical trial phases and therapeutic areas. The role combines scientific expertise, operational oversight, and people leadership to support patient safety and regulatory compliance across global studies. The manager guides and develops pharmacovigilance professionals and oversees project delivery, quality, timelines, and scope, while contributing to continuous improvement and partnering with internal teams and external stakeholders. This is a remote role open to candidates based in the United States. The person will collaborate with global teams across multiple time zones.
Requirements
- Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience.
- At least 5 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple phases and therapeutic areas.
- At least 2 years of leadership experience in a mentorship, supervisory, or people-development capacity.
- Strong knowledge of pharmacovigilance regulations, adverse event assessment, regulatory reporting requirements, SOPs, and accepted clinical trial practices.
- Experience with safety databases, data extraction processes, and Microsoft Office applications, including Excel, Word, and PowerPoint.
- Ability to manage multiple priorities, work independently, and collaborate effectively in a matrix environment.
- Strong interpersonal, presentation, and stakeholder management skills, including confidence interacting with sponsors, clients, and cross-functional teams.
- Fluency in written and verbal English.
Responsibilities
- Lead and oversee pharmacovigilance projects and teams, ensuring activities comply with applicable regulations, SOPs, and project requirements.
- Manage project delivery against quality, timeline, and budget expectations, proactively identifying and escalating risks or issues.
- Coach, mentor, and develop direct reports, fostering accountability, collaboration, and continuous improvement.
- Provide guidance on safety-related regulations, reporting requirements, and pharmacovigilance best practices across assigned projects.
- Monitor project scope and resource requirements, escalating potential changes and supporting operational efficiency.
- Support departmental recruitment, onboarding, training, and knowledge-sharing activities.
- Contribute to proposal reviews, budget discussions, bid defense meetings, and SOP development as needed.
- Represent Pharmacovigilance during sponsor audits and act as a backup to senior PV leadership when required.
- Participate in departmental and company-wide initiatives that enhance operational excellence and service delivery.
Benefits
- Competitive benefits package, depending on location.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
