Safety Operations Director

Job Summary

Overseeing the multidisciplinary arena of Patient Safety Operations, the full-time Safety Operations Director will manage drug safety operations, ensuring compliance with regulatory requirements and collaborating with cross-functional teams in a dynamic environment.

Key responsibilities

• Lead day-to-day drug safety operations for clinical and post-marketing programs
• Manage case processing workflows and quality assurance in partnership with internal and external teams
• Ensure compliance with safety vendor agreements and support regulatory inspections and audits

Required qualifications

• At least 10 years of experience in drug safety and pharmacovigilance
• Degree in life sciences or equivalent experience
• Proficiency in Argus; familiarity with Veeva, eTMF, and EDC preferred
• Strong understanding of global pharmacovigilance regulations (ICH, FDA, EMA, MHRA, etc.)
• Prior experience with inspections or audits is strongly preferred