Associate Director, Pharmacovigilance (US)
Worldwide Clinical Trials
Summary
As an Associate Director, Pharmacovigilance, you will play a critical leadership role in delivering high-quality global pharmacovigilance services that support clinical development programs across a variety of therapeutic areas and trial phases. Your expertise will help ensure patient safety, regulatory compliance, and operational excellence while guiding teams through complex safety reporting challenges.
Job description
Make an Impact as an Associate Director, Pharmacovigilance at Worldwide
As an Associate Director, Pharmacovigilance, you will play a critical leadership role in delivering high-quality global pharmacovigilance services that support clinical development programs across a variety of therapeutic areas and trial phases. Your expertise will help ensure patient safety, regulatory compliance, and operational excellence while guiding teams through complex safety reporting challenges.
In this role, you will provide strategic and operational oversight of pharmacovigilance projects and staff, partnering with global stakeholders to drive quality, efficiency, and continuous improvement. You will also contribute to the evolution of department processes, technology, and talent development while serving as a trusted advisor to clients and internal teams on global safety requirements and best practices.
Your leadership will have a direct impact on the successful delivery of pharmacovigilance services, supporting both business growth and Worldwide's commitment to advancing clinical research.
Where You'll Work
This is a REMOTE role open to candidates based in US. You will collaborate with global teams across multiple time zones.
What You'll Do
- Lead global pharmacovigilance projects and teams, ensuring activities are delivered in compliance with applicable regulations, quality standards, and project timelines.
- Provide strategic oversight of staff and project performance, addressing risks, issues, and escalations to support successful study execution.
- Guide teams on complex safety reporting scenarios and sponsor requirements, serving as a key point of expertise and decision-making.
- Partner with department leadership to enhance processes, implement efficiencies, and support ongoing technology and operational improvements.
- Contribute to proposal development, budget reviews, bid defense meetings, and scope management activities.
- Support team growth through coaching, training, recruitment, onboarding, and 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.
- Act as a key contributor to departmental and company-wide initiatives while providing backup support to senior pharmacovigilance leadership when required.
What You'll Bring
- Bachelor's degree in a science-related field, nursing, or equivalent combination of education and relevant experience.
- Minimum of 8 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple therapeutic areas and study phases.
- Demonstrated leadership experience, including at least 2 years in a people, project, or departmental leadership capacity.
- Strong knowledge of global pharmacovigilance regulations, safety reporting requirements, adverse event assessment, and clinical trial best practices.
- Proven 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.
Requirements
- Bachelor's degree in a science-related field, nursing, or equivalent combination of education and relevant experience.
- Minimum of 8 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple therapeutic areas and study phases.
- Demonstrated leadership experience, including at least 2 years in a people, project, or departmental leadership capacity.
- Strong knowledge of global pharmacovigilance regulations, safety reporting requirements, adverse event assessment, and clinical trial best practices.
- Proven 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.
Benefits
- Competitive benefits package
Company overview
Worldwide Clinical Trials is a leading global contract research organization (CRO) that provides comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. Founded with a mission to accelerate the development of innovative therapies, the company offers end-to-end solutions spanning from early-phase research through late-stage clinical trials and regulatory submissions. With expertise across multiple therapeutic areas including oncology, central nervous system disorders, cardiovascular diseases, and rare conditions, Worldwide Clinical Trials leverages its scientific knowledge and operational excellence to design and execute complex clinical studies. The organization maintains a global footprint with operations across North America, Europe, and Asia-Pacific regions, enabling it to conduct multinational trials efficiently. Known for its patient-centric approach and commitment to quality, Worldwide Clinical Trials plays a crucial role in advancing medical research and bringing new treatments to patients worldwide.