Director of Patient Safety Operations

Job Summary

Overseeing the multidisciplinary arena of Patient Safety Operations, the full-time salaried Director of Patient Safety Operations will manage drug safety operations, ensure compliance with regulatory requirements, and collaborate cross-functionally to enhance pharmacovigilance processes.

Key responsibilities

• Lead and oversee day-to-day drug safety operations for clinical and post-marketing programs
• Manage case processing workflows and collaborate with internal and external teams to ensure quality assurance
• Support the development and maintenance of SOPs and ensure readiness for regulatory inspections and audits

Required qualifications

• At least 10 years of experience in drug safety and pharmacovigilance
• Degree in life sciences or equivalent experience
• Experience with Argus; familiarity with Veeva, eTMF, and EDC preferred
• Prior involvement in inspections or audits is strongly preferred
• Demonstrated ability to manage complex operational projects across global timelines