New Jersey 732.770.4100

 Drug Safety and Pharmacovigilance Operations

Our project managers are responsible for the overall conduct of a Safety study, ensuring PV and Clinical Quality Assurance, Reporting and Medical Writing and Reporting, Evaluation, and Assessment. They provide leadership and oversight to our study teams and serve as a single point of contact for our sponsors. Qtech offers comprehensive services that supports various Pharmacovigilance Operations on time and on-budget.
Our experienced Drug Safety Physicians, Drug Safety and Pharmacovigilance Officers support monitoring, data collection and analysis, and reporting of medical safety information for compliance and meet regulations imposed.
Services Offered:
  • Preparing and Submission of safety reports
  • Processing Adverse event reports
  • Case processing and Management
  • Writing case narratives
  • Triage
  • ICSR Medical Causality assessment
  • Performing safety audits for the trial clinical data
  • Ensuring compliance with the MedDRA
  • SOP development
  • SAE Reconciliation
  • Signal Detection & Evaluation
  • Risk Management - REMS
  • Drug Safety Database - Oracle ARGUS
  • Medical Writing and Reviews
  • Corrective and Preventative Actions (CAPA) Management
  • Aggregate Report Writing (PSUR/ PBRER/ PADER/ DSUR)

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