Manager, Pharmacovigilance

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Lead and manage pharmacovigilance projects and teams while ensuring adherence to regulations, SOPs, and project specifications.

• Oversee project delivery to meet quality standards, timelines, and budgetary constraints; proactively identify and address risks or issues.

• Coach, mentor, and foster the professional development of direct reports.

• Provide expertise on safety regulations, reporting obligations, and best practices in pharmacovigilance.

• Monitor project scope and resource needs, escalating modifications and enhancing operational efficiency.

• Assist in recruitment, onboarding, training, and knowledge-sharing initiatives.

• Contribute to proposal reviews, budget negotiations, bid defense meetings, and the creation of SOPs.

• Represent the Pharmacovigilance team during sponsor audits and support senior PV leadership.

• Engage in departmental and organization-wide operational excellence initiatives.

⛳️ Requirements

• Bachelor’s degree in a science-related discipline, nursing, or a comparable combination of education and relevant experience.

• A minimum of 5 years of global pharmacovigilance experience supporting pre-approval clinical trials across various phases and therapeutic areas.

• At least 2 years of experience in a mentorship, supervisory, or people-development role.

• Comprehensive knowledge of pharmacovigilance regulations, adverse event assessment, regulatory reporting requirements, SOPs, and standard clinical trial practices.

• Proficient in working with safety databases, data extraction processes, and Microsoft Office applications, including Excel, Word, and PowerPoint.

• Capability to handle multiple priorities, work autonomously, and collaborate efficiently within a matrix environment.

• Excellent interpersonal, presentation, and stakeholder management skills, with experience in engaging with sponsors, clients, and cross-functional teams.

• Proficiency in written and spoken English.

🏝️ Benefits

• Comprehensive healthcare coverage.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and growth.

• Flexible work arrangements and a supportive work environment.