Our Services
CANDOR Vigilance offers PV, PV Quality Assurance, auditing, and training services to clients in the Asia Pacific, Australiasia, and the U.S. (west coast) regions.
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Pharmacovigilance Audits
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System/Process
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Affiliates
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External Service Provider
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Licensing Partner
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Pre-Inspection assessment
Each audit typically includes planning, preparation, and reporting according to the client's requirements and procedures. If required, CAPA management and/or follow-up activities such as CAPA review, approval, and follow-up to completion may be arranged.
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Risk Assessments
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Risk Assessment of all audit entity types for in the PV audit universe
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Documentation of the Risk Assessment Strategy
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Development of the Annual Audit Schedule / Audit Plan
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Risk Assessment Tool development
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Inspection support
Anteroom support - various roles, including:
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Anteroom lead
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Inspection Request Tracking
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QA reviewer, QC of inspection responses
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Scribe during interview sessions
With experience in remote, onsite, and hybrid settings.
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Training
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Basic PV and refresher training
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Basic audit training
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PV audit practical training
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Audit and Inspection readiness training
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The scope of training and requirements will be discussed and tailored to the client's needs. Training may include workshops, competency assessment, and documentation as required.
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Pharmacovigilance support
Open to a range of projects
Let's Work Together
Please get in touch, we look forward to hearing from you.