Associate Director of Drug Safety

Job Summary

Providing strategic and operational leadership for clinical safety activities, the full-time remote Associate Director of Drug Safety will manage safety operations, oversee external vendors, and ensure compliance with global regulatory requirements across clinical trials.

Key responsibilities

• Lead oversight of external safety vendors to ensure timely and compliant execution of safety activities
• Prepare and review aggregate safety reports and manage associated timelines and inputs from cross-functional teams
• Oversee the assessment of adverse event reports and ensure timely reporting in accordance with global regulations

Required qualifications

• 10+ years of drug safety/pharmacovigilance experience within a sponsor environment or a combination of sponsor and CRO roles
• Bachelor's or advanced degree in a life science or healthcare-related discipline
• Comprehensive knowledge of global clinical safety regulations and industry best practices
• Extensive experience with commercial safety databases and preparing aggregate safety reports
• Strong knowledge of MedDRA and WHODrug coding conventions