Drug Safety Operations Manager

Job Summary

A company is looking for a Manager / Senior Manager, Drug Safety Operations.

Key Responsibilities

• Manage and oversee safety vendors responsible for case processing and related pharmacovigilance activities
• Oversee case processing activities, maintain trackers for safety-related data, and manage pharmacovigilance agreements
• Ensure accurate data entry in the safety database and provide operational expertise during audits and inspections

Required Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred
• Minimum 7+ years in drug safety/pharmacovigilance operations within biotech or pharmaceutical industry
• Proven experience managing safety vendors and overseeing case processing activities
• Hands-on experience with pharmacovigilance agreements and safety database management
• Strong knowledge of global PV regulations and GVP guidelines