Overview
Veterinary Pharmacovigilance Specialist Jobs in Kalamazoo, Michigan, USA 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 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 feedback in day-to-day 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:
Bachelor’s degree in life sciences, animal health, veterinary medical technology, veterinary medicine, nursing, pharmacy, biochemistry, zoology or a related discipline. Master’s degree is a plus.
3 to 5 years of experience in the pharmaceutical/biotechnology area and/or quality-related area.
Experience in the pharmaceutical industry within the regulated area of pharmacovigilance.
Experience with case data entry in applicable PV database and/or case quality requirements is preferred.
Experience in AI, machine learning and/or advanced MS Office would be an asset.
Experience working in an international, multicultural, and transversal environment.
Familiarity with GxP systems in the pharmaceutical industry, including knowledge of applicable regulations, computerized system validation, GXP principles, and practices.
Familiarity with statistical, quality, and data integrity principles.
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.
Paid vacation and holidays.
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Eurofins USA PSS Insourcing Solutions is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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Title: Veterinary Pharmacovigilance Specialist
Company: Eurofins USA PSS Insourcing Solutions
Location: Kalamazoo, Michigan, USA
Category: Healthcare, Quality Assurance – QA/QC
