Associate Director, Pharmacovigilance (US)
About The Position
The Associate Director, Pharmacovigilance provides leadership and strategic and operational oversight for global pharmacovigilance projects and staff. The role supports clinical development programs across therapeutic areas and trial phases, helping ensure patient safety, regulatory compliance, quality, and operational excellence. The position guides teams through complex safety reporting scenarios, advises clients and internal stakeholders on global safety requirements and best practices, and addresses project risks, issues, and escalations. Working in partnership with department leadership and global stakeholders, the Associate Director helps improve processes, technology, and operational efficiency. The role also supports proposal development, budgeting, business development, client-facing activities, and the growth and development of pharmacovigilance professionals. This is a remote position open to candidates based in the United States, collaborating with global teams across multiple time zones.
Requirements
- Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience.
- At least 8 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple therapeutic areas and study phases.
- At least 2 years of people, project, or departmental leadership experience.
- Strong knowledge of global pharmacovigilance regulations, safety reporting requirements, adverse event assessment, and clinical trial best practices.
- Experience managing budgets, scope, timelines, quality standards, and cross-functional stakeholder relationships.
- Strong understanding of pharmacovigilance systems, relational databases, and Microsoft Office applications, including Excel, PowerPoint, and Word.
- Excellent organizational, interpersonal, presentation, and communication skills, with the ability to influence, mentor, and guide teams in a matrix environment.
- Proficiency in written and verbal English.
Responsibilities
- Lead global pharmacovigilance projects and teams, ensuring compliance with applicable regulations, quality standards, and project timelines.
- Provide strategic oversight of staff and project performance and address risks, issues, and escalations.
- Guide teams on complex safety reporting scenarios and sponsor requirements, serving as an expert and decision-maker.
- Partner with department leadership to improve processes, implement efficiencies, and support technology and operational improvements.
- Contribute to proposal development, budget reviews, bid defense meetings, and scope management.
- Coach, train, recruit, onboard, and support the development of pharmacovigilance professionals.
- Represent Pharmacovigilance during sponsor audits, client consultations, and other external-facing activities as needed.
- Participate in business development initiatives, including conference presentations, marketing efforts, and thought leadership activities.
- Contribute to departmental and company-wide initiatives and provide backup support to senior pharmacovigilance leadership when required.
Benefits
- Competitive benefits package; specific benefits depend on location.
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What This Job Offers
Job Type
Full-time
Career Level
Director
