Manager, Pharmacovigilance

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

📋 Description

• Lead and manage pharmacovigilance projects and team activities to ensure adherence to relevant regulations, guidelines, and internal protocols.

• Oversee project delivery to meet established timelines, quality standards, and budget constraints.

• Provide coaching, mentorship, and development opportunities for team members.

• Identify, escalate, and assist in resolving study, operational, or personnel-related challenges.

• Maintain a deep understanding of global safety regulations, reporting obligations, and best practices in pharmacovigilance.

• Support project planning activities, including scope management, proposal evaluations, budget discussions, and participation in bid defenses.

• Organize and implement training programs.

• Contribute to the recruitment, onboarding, and professional growth of staff.

• Act as a representative of Pharmacovigilance during sponsor audits.

• Participate in departmental or company-wide initiatives.

• Provide leadership support and serve as a backup for senior pharmacovigilance leadership.

⛳️ Requirements

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

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

• Minimum of 2 years in a mentorship or leadership role.

• Strong understanding of clinical trial safety procedures, pharmacovigilance regulations, regulatory reporting obligations, SOPs, and industry best practices.

• Excellent knowledge of medical and scientific terminology, adverse event evaluation, and safety database technologies.

• Demonstrated ability to manage multiple priorities, work autonomously, and collaborate effectively within matrixed global teams.

• Strong interpersonal, presentation, and stakeholder management abilities, with experience engaging sponsors, clients, and cross-functional teams.

• Proficiency in both written and spoken English.

• Exceptional communication, organizational, and attention-to-detail skills.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable work environment.

• Opportunities for professional growth and development.

• Training and professional development programs.