Manager, Pharmacovigilance (US)
About The Position
The Manager, Pharmacovigilance leads pharmacovigilance projects and team operations supporting the safe development of investigational therapies in global clinical trials. The role oversees project delivery, quality, timelines, and scope across studies and therapeutic areas while ensuring compliance with international regulations, reporting standards, and internal processes. It also involves developing pharmacovigilance professionals, supporting project planning and business development activities, representing the department during sponsor audits, and contributing to departmental and company-wide initiatives. This is a remote role open to candidates based in the United States, with collaboration across global teams and time zones.
Requirements
- Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience.
- Minimum 5 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple phases and therapeutic areas.
- At least 2 years of mentorship or people leadership experience.
- Strong knowledge of clinical trial safety processes, pharmacovigilance regulations, regulatory reporting requirements, SOPs, and industry best practices.
- Excellent understanding of medical and scientific terminology, adverse event assessment, and safety database technologies.
- Ability to manage multiple priorities, work independently, and collaborate effectively within matrixed global teams.
- Strong interpersonal, presentation, and stakeholder management skills, including experience engaging sponsors, clients, and cross-functional colleagues.
- Proficiency in written and verbal English, with excellent communication, organizational, and attention-to-detail skills.
Responsibilities
- Lead and oversee pharmacovigilance projects and team operations to ensure compliance with applicable regulations, guidelines, and internal processes.
- Manage project delivery against agreed timelines, quality expectations, and budgeted scope of work.
- Coach, mentor, and develop team members, providing ongoing guidance and support to promote high performance.
- Identify, escalate, and help resolve study, operational, or staff-related issues to support successful project outcomes.
- Maintain expertise in global safety regulations, reporting requirements, and pharmacovigilance best practices.
- Support project planning activities, including scope management, proposal reviews, budget discussions, and bid defense participation as needed.
- Organize and deliver training initiatives and contribute to staff recruitment, onboarding, and professional development efforts.
- Represent Pharmacovigilance during sponsor audits and contribute to departmental or company-wide initiatives as required.
- Provide leadership support and serve as a backup to senior pharmacovigilance leadership when needed.
Benefits
- Competitive benefits package, depending on location.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
