A pharmacovigilance program is a set of activities and procedures aimed at detecting, assessing, understanding, and preventing adverse reactions to medicine or vaccines by identifying, assessing, and understanding these adverse reactions. Before a medicine or vaccine is approved for use, it must undergo rigorous testing by clinical trials in order to ensure the safety and effectiveness of the product.
Pharmacovigilance and Drug Safety Services
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ADVERSE EVENT REPORTING
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CLINICAL CASE CODING
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NARRATIVE WRITING
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SAFETY DATABASE SERVICES
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AGGREGATE SAFETY REPORTS
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RISK MANAGEMENT
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PERIODIC SAFETY UPDATE REPORTS (PSUR),
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BENEFIT-RISK EVALUATION REPORT (PBRER)
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PERIODIC ADVERSE DRUG EXPERIENCE REPORT (PADER)
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DEVELOPMENTAL SAFETY UPDATE REPORT (DSUR)
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INVESTIGATIONAL NEW DRUG (IND) – ANNUAL REPORT
SAFETY/ RISK MANAGEMENT PLAN -
SIGNAL DETECTION AND ANALYSIS
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ADVERSE EVENT AND PRODUCT
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COMPLAINT MANAGEMENT
PHARMACOVIGILANCE CONSULTING -
SIGNAL DETECTION AND ANALYSIS