PCS is rooted in pharmacovigilance and offers 30 years of experience in Drug Safety monitoring, trend identification, and compliant report processing.  Efficient Standard Operating Procedures are an advantage in managing your Drug Safety needs.

Services offered:

• Pharmacovigilance and Medical Information call center
• Adverse drug event collection, assessment, and reporting
• Database set up and user validation
• GPvP auditing and mock audit exercises
• Certified MedDRA Coding
• Periodic report writing (PADER, PSUR, DSUR, PBRER)
• SAE narrative writing
• Health Hazard Assessment
• Risk Assessments and Clinical Significance
• Recall support