MEDICAL AFFAIRS AND VIGILANCE
MEDICAL AFFAIRS AND VIGILANCE
Your vigilance partner on the ground
Product Types
Finding the correct approach to product registration.
Vicore specialises in medical affairs services and vigilance requirements of the following product types across a range of therapeutic areas:
- Pharmaceutical Medicines
- Complementary Medicines
- Medical Devices and IVDs
- Cosmetics
- Borderline Products
Services
PV Oversight for MAH
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Oversight of Adverse Drug Reaction, Product Quality Complaints and Medical information for pharmaceuticals and medical devices
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QPPV contracts and notifications to Regulatory bodies
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Periodic reconciliation of PV information
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Database and access logs
PV Management
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PV report center
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Audit preparation and auditing
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Consultancy and guidance for the development of SOPs and PV practices
PV Intelligence
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Surveillance of regulatory changes, communication and escalation as required
Medical Information
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Resource provision and customer centric query resolution
Literature Screening
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Review of medical literature and escalation of adverse events
Medical and Commercial Excellence
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Product and therapy area training