pharmacovigilance outsourcing


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Activities that can be outsourced pt 1

admin @ # 17 Comments

ROUTINE DATA PROCESSING:
This includes receiving the safety data from the public and from health professionals, triage of routine cases to determine seriousness, entry of the data into a validated pharmacovigilance database, coding the narrative and providing medical review and surveillance of cases.
EXPEDITED REPORTING:
All reports of serious adverse events have to be reported to regulatory authorities [...]

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implications of outsourcing

admin @ # 6 Comments

When people mention outsourcing the implication is often that the work is being outsourced overseas where labour is cheaper, but that quality of work may be lower too. For many companies the cost factors are the prime driving force but in pharmacovigilance where the suspension of a drug can cost a pharmaceutical company billions, quality [...]

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