Senior Director of Drug Safety Operations

Job Summary

Seeking a highly experienced Senior Director of Drug Safety Operations, this full-time remote position will manage global safety operations, oversee pharmacovigilance activities, and ensure compliance with regulatory requirements while leading a high-performing team.

Key responsibilities

• Lead Drug Safety Operations activities, ensuring timely and compliant safety information collection and reporting across clinical programs
• Oversee pharmacovigilance operations, including case processing, regulatory submissions, and vendor management
• Drive operational excellence through process optimization and continuous improvement initiatives in alignment with corporate objectives

Required qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related scientific discipline
• 10+ years of experience in pharmacovigilance and drug safety operations within the biotechnology or pharmaceutical industry
• Demonstrated experience managing global safety operations and regulatory submissions in a GxP-regulated environment
• Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH requirements
• Experience with safety databases and pharmacovigilance technologies, including familiarity with MedDRA and E2B(R3) reporting standards