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Manager, Pharmacovigilance
Worldwide Clinical TrialsCore Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading pharmacovigilance projects, ensuring compliance with regulations and best practices while managing project delivery and team development. Proficient in stakeholder management and operational efficiency within clinical trial environments.
About the role
Key responsibilities & impact- Lead and oversee pharmacovigilance projects and teams in compliance with regulations, SOPs, and project requirements
- Manage project delivery against quality, timeline, and budget expectations; identify and escalate risks or issues
- Coach, mentor, and develop direct reports
- Provide guidance on safety regulations, reporting requirements, and pharmacovigilance best practices
- Monitor project scope and resource requirements, escalating changes and supporting operational efficiency
- Support recruitment, onboarding, training, and knowledge-sharing initiatives
- Contribute to proposal reviews, budget discussions, bid defense meetings, and SOP development
- Represent Pharmacovigilance during sponsor audits and back up senior PV leadership
- Participate in departmental and company-wide operational excellence initiatives
Requirements
What you’ll need- 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 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 working 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 within a matrix environment
- Strong interpersonal, presentation, and stakeholder management skills with experience interacting with sponsors, clients, and cross-functional teams
- Fluency in written and verbal English
ATS Keywords
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