California Licensed Pharmacovigilance Manager

Job Summary

California Licensed Pharmacovigilance Manager, this fully remote contract position involves managing ICSR quality, ensuring vendor compliance, and maintaining accountability for FDA and EMA reporting.

Key Responsibilities

• Perform comprehensive case reviews and ensure reporting compliance with global timelines
• Oversee the quality of US Individual Case Safety Reports (ICSRs) for clinical trials and post-marketing
• Manage key vendor relationships and facilitate E2B submission support

Required Qualifications

• Prior pharmacovigilance experience or direct exposure
• Strong understanding of global regulatory requirements for pharmacovigilance
• Proficiency in safety database usage and medical coding
• Master's degree OR Bachelor's degree with 2 years of experience OR Associate's degree with 6 years of experience
• Note: Candidates with an MBBS or MD degree will not be considered