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Pharmacovigilance:
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Setup and maintenance of global safety databases
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Receiving, processing and archiving adverse events and reaction information
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Medical assessment of individual cases
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Contribution to risk signal detection
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Risk management strategy
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Ensure compliance with local and international requirements
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Safety reporting to Health Authorities and other parties
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MedDRA coding and coding convention strategies
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Medical support for SAE reconciliation
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Preparation of written pharmacovigilance procedures (SOPs)
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Preparation of SAE case narratives
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Interim safety reports (on demand)
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Annual safety reports
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Periodic Safety Update Reports (PSUR)
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QPPV services
For more information email us at info@pharexcelconsulting.com or contact us today.
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