Associate Director, Pharmacovigilance

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

📋 Description

• Oversee global pharmacovigilance initiatives and teams

• Ensure activities are in line with regulations, quality benchmarks, and project deadlines

• Provide strategic direction for staff and project outcomes

• Identify and address risks, issues, and escalations to support successful study execution

• Advise teams on intricate safety reporting situations and sponsor requirements

• Collaborate with department leadership to refine processes and introduce efficiencies

• Assist in technology and operational enhancements

• Contribute to proposal creation, budget evaluations, bid defense meetings, and scope management

• Mentor, train, recruit, onboard, and develop pharmacovigilance professionals

• Act as a representative for Pharmacovigilance during sponsor audits, client meetings, and other external engagements

• Engage in business development, conference presentations, marketing, and thought leadership initiatives

• Contribute to both departmental and company-wide projects

• Provide support to senior pharmacovigilance leadership as needed

⛳️ Requirements

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

• At least 8 years of global pharmacovigilance experience supporting pre-approval clinical trials across various therapeutic areas and study phases

• Minimum of 2 years in a leadership role involving people, projects, or departments

• Comprehensive knowledge of global pharmacovigilance regulations, safety reporting mandates, adverse event evaluation, and clinical trial best practices

• Proven experience in managing budgets, scope, timelines, quality standards, and relationships with cross-functional stakeholders

• Strong understanding of pharmacovigilance systems, relational databases, and Microsoft Office applications, including Excel, PowerPoint, and Word

• Exceptional organizational, interpersonal, presentation, and communication skills

• Proficient in both written and spoken English

🏝️ Benefits

• Competitive benefits package based on location

• Commitment to an inclusive and equitable workplace

• Equal employment opportunities for all

• Collaborative and inclusive work environment

• Opportunities for growth and development

• Access to coaching, training, recruitment, onboarding, and professional development resources