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Pharmacovigilance Quality Specialist
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)
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)