Be Part of a High-Performing Team:

A rapidly growing biopharmaceutical organization is expanding its Pharmacovigilance Quality Assurance function. This team is responsible for ensuring vendor oversight, supplier compliance, and inspection readiness across global drug safety operations. With a strong focus on collaboration, accountability, and continuous improvement, the team plays a critical role in safeguarding patient safety and supporting innovative therapies.

What’s In Store For You:

• A fully remote opportunity with preference for East Coast-based candidates.
• A chance to shape and strengthen vendor oversight processes in a growing QA function.
• Direct collaboration with procurement, legal, and commercial teams.
• Involvement in inspection readiness and continuous process improvement initiatives.

How You Will Make an Impact:

• Lead vendor oversight activities, including supplier qualification, risk assessments, and ongoing monitoring.
• Manage vendor setup and compliance documentation in Veeva Vault.
• Support and/or conduct audits of PV-related vendors.
• Review and approve deviations, CAPAs, and risk assessments.
• Contribute to Pharmacovigilance System Master File (PSMF) updates.
• Provide inspection readiness support, including preparation and response activities.
• Drive process improvements within SOPs, QMS, and QA practices.

Are You an Experienced Pharmacovigilance QA Professional Ready to Make an Impact?

• Bachelor’s degree in Chemistry, Biology, or related life sciences (required).
• 4–5 years of experience in Pharmacovigilance QA/Compliance (non-case handling).
• Proven experience managing PV vendor oversight and supplier management.
• Familiarity with procurement workflows, contractual agreements (MSAs, SDEAs), and regulatory compliance.
• Strong knowledge of QMS, CAPA management, deviations, and inspection readiness.
• Excellent communication, organizational, and collaboration skills.

Preferred:

• Audit leadership experience.
• Advanced degree (MS, PhD, MBA).
• Exposure to global PV compliance and promotional review processes.