Pharma covigilance
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
ADVERSE EVENT REPORTING
CLINICAL CASE CODING
NARRATIVE WRITING
SAFETY DATABASE SERVICES
AGGREGATE SAFETY REPORTS
RISK MANAGEMENT
PERIODIC SAFETY UPDATE REPORTS (PSUR),
BENEFIT-RISK EVALUATION REPORT (PBRER)
PERIODIC ADVERSE DRUG EXPERIENCE REPORT (PADER)
DEVELOPMENTAL SAFETY UPDATE REPORT (DSUR)
INVESTIGATIONAL NEW DRUG (IND) – ANNUAL REPORT
SAFETY/ RISK MANAGEMENT PLANSIGNAL DETECTION AND ANALYSIS
ADVERSE EVENT AND PRODUCT
COMPLAINT MANAGEMENT
PHARMACOVIGILANCE CONSULTINGSIGNAL DETECTION AND ANALYSIS
