What are the responsibilities and job description for the Case Quality Check Specialist - Animal/Veterinary Pharmacovigilance position at Eurofins USA PSS Insourcing Solutions?
Job Description
The Pharmacovigilance (PV) Case Quality Check (CQC) Specialist plays a critical role in ensuring the accuracy, completeness, and compliance of pharmacovigilance cases. This position involves meticulous review and validation of safety data and documentation to guarantee adherence to regulatory requirements and internal standards. The specialist will collaborate with cross-functional teams to identify and rectify discrepancies, contributing to the overall quality of pharmacovigilance processes.
Essential Duties and Responsibilities
- Conduct comprehensive reviews of the assigned the PV cases, following process requirements and alignment with the CQC Lead.
- Verify the consistency, accuracy and completeness of the data entered in the global PV, adhering to the regulatory requirements and internal procedures.
- Document the identified errors or inconsistencies in alignment as per the process requirements.
- Provide feedback for case corrections to countries / country Point of Contact (POC).
- Support maintaining a focus on quality in process delivery.
- Implement communicated functional and operational process changes, requirements, and feedbacks in day-today operations.
- Timely notify and escalate any identified gaps, trends observed during conduct of CQC, areas of improvement, or process-related feedback or requests received from internal or external stakeholders to the CQC Lead.
- Actively collaborate and consult with the CQC Lead to address and resolve these issues in a timely manner.
- Collaborate with the CQC Lead to support the development and maintenance of the process standards and outputs. Contribute to continuous improvement initiatives, as needed.
- Seek opportunities to improve the overall quality of case reviews by incorporating feedback into daily CQC to meet the expected quality standard.
- Assist the CQC Lead during audits and regulatory inspections to the extent agreed and as required.
- Assist CQC Lead in planning corrective / preventive actions, as applicable.
- Participate in various meetings and discussions, as applicable, contributing in alignment with the CQC Lead.
Qualifications
Additional Information
Position is full-time, First Shift, Monday-Friday 8AM-5PM.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
LI-EB1
Eurofins USA PSS Insourcing Solutions is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
