Director of Safety Operations

Job Summary

A company is looking for a Director of Safety Operations to oversee safety operations activities in pharmacovigilance and clinical development.

Key Responsibilities

• Oversee safety operations activities with external partners and vendors, ensuring compliance with safety reporting processes
• Lead the development and management of study-specific safety management plans and monitor vendor performance
• Conduct safety data reviews and collaborate on the preparation of key pharmacovigilance documents for regulatory submissions

Required Qualifications

• Advanced degree with a minimum of 5+ years of experience in drug safety operations, preferably in oncology
• Proven experience in vendor management and oversight of safety vendors
• Strong expertise in utilizing safety databases and safety coding dictionaries
• In-depth knowledge of international safety reporting regulations and best practices
• Comprehensive understanding of pre- and post-marketing drug safety standards, particularly in oncology