Pharmacovigilance Quality Specialist

Job Summary

A company is looking for a Pharmacovigilance Quality Sr. Specialist.

Key Responsibilities

• Perform quality review of responses to FDA requests
• Develop quality metrics and prepare periodic reports based on metrics and quality trends
• Participate in the CAPA process and ensure reported deviations and incidents are properly managed and escalated

Required Qualifications

• 4-year degree BA/BS in the life sciences, required
• At least 2 years of relevant pharmaceutical industry experience, including exposure to quality and compliance activities
• Minimum of 3 years of experience working in the pharmaceutical industry, preferably in a Pharmacovigilance Department, required
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA
• Excellent computer skills (Microsoft Word, Excel, Outlook)