Pharmacovigilance Associate Director

Job Summary

To establish and lead U.S. pharmacovigilance operations, the full-time Associate Director, Pharmacovigilance will manage client-facing programs, develop operational processes, and collaborate with global teams in a remote capacity.

Key Responsibilities

• Establish and develop the operational structure and processes for U.S. pharmacovigilance services
• Independently manage pharmacovigilance projects, ensuring compliance and quality throughout the project lifecycle
• Provide technical oversight for safety reporting activities and collaborate with cross-functional teams for coordinated safety oversight

Required Qualifications

• Bachelor's degree or higher in Pharmacy, Medicine, Nursing, Life Sciences, or a related field
• At least 8 years of experience in pharmacovigilance or drug safety, with a focus on clinical development programs
• Strong knowledge of FDA pharmacovigilance regulations and ICH guidance
• Experience in managing pharmacovigilance projects with a focus on client communication and operational oversight
• Hands-on understanding of safety case processing and regulatory reporting