Senior Pharmacovigilance Specialist

Job Summary

Leading global post-marketing case processing activities, the full-time Senior Pharmacovigilance Specialist will develop workflows, ensure compliance with regulatory standards, and manage client interactions in a remote setting.

Key responsibilities

• Oversee post-marketing case processing from intake through reporting and closure
• Develop and maintain pharmacovigilance workflows and ensure compliance with Good Pharmacovigilance Practices and FDA requirements
• Independently manage client meetings and provide mentorship to team members

Required qualifications

• College graduate in a scientific, medical, or clinical discipline; advanced degrees preferred
• Minimum of 5 years' experience in drug safety or pharmacovigilance
• Expert knowledge of drug safety databases and scientific principles
• Proficiency with MS Office applications
• Familiarity with regulatory standards such as ISO 9001, ISO 27001, and 21 CFR Part 11