Pharmacovigilance Manager

Job Summary

A company is looking for a Manager, PVRM.

Key Responsibilities

• Manage the benefit/risk profile of assigned products and ensure patient safety
• Assist in signal detection activities and lead aggregate safety report activities
• Coordinate responses to ad hoc safety issues and support collaboration with external partners

Required Qualifications

• Bachelor's degree in a health care/life science related field; Master's or other graduate degree preferred
• Minimum 3 years of experience in Pharmacovigilance within the pharmaceutical industry
• Prior experience in oncology and/or neurology is strongly preferred
• Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines
• Proficiency with safety databases and software, including tools such as Argus and Oracle