Quality Systems Specialist
1 day ago
Civica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure the consistent availability of affordable medications, particularly for those who need them most.
Job DescriptionThe Quality Systems Specialist - Complaints will join our team at the Petersburg, Virginia site, where we manufacture and supply essential generic sterile injectable medications. This role is critical to ensuring our product portfolio meets pharmacovigilance expectations and prioritizes patient safety.
Key Responsibilities- Manage market complaints and adverse events for our product portfolio, ensuring timely submission to applicable health authorities.
- Process complaints assigned according to relevant SOPs, maintaining accurate quality system records.
- Support our pharmacovigilance program, collaborating with cross-functional teams to ensure compliance and regulatory requirements are met.
- Author procedural documents and interpret compliance and regulatory requirements for incorporation into our pharmacovigilance program.
- Track, trend, and analyze pharmacovigilance metrics for the site, identifying areas for improvement.
- Bachelor's degree with 4+ years of pharmacovigilance/complaints or related quality system experience within a regulated industry.
- Strong organizational, analytical, and execution skills, with a proven track record of managing multiple projects and priorities.
- Excellent interpersonal, verbal, and written communication skills, with experience using various software/electronic applications.
- Self-motivated, flexible, and able to work in a fast-paced, dynamic environment.
Civica is committed to delivering high-quality results, working collaboratively to overcome challenges, and focusing on what matters. We offer a dynamic work environment, opportunities for growth and development, and a chance to make a meaningful impact in the lives of patients.
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