Pharmacovigilance Services

August Research’s Pharmacovigilance Services are focused on providing high-quality, customized solutions for clinical trial sponsors and CROs, from our PV center in Sofia, Bulgaria.

Our services include:

Safety Management Strategies – Developing project specific Safety Management Plans (SMPs) for drugs, biologics and vaccines and strategies to ensure clear communication and inspection readiness.

Safety Database Hosting – Low cost, flexible database system providing regulatory compliant case processing and report generation.

Individual Case Safety Reports (ICSR) Processing – European-based case processing by Health Care Professionals with an average of 11 years of Pharmacovigilance experience focused on:

  • quality
  • thoughtful follow-up due diligence
  • timely distribution to authorities and partners
Regulatory Reporting – Continual monitoring of Safety Regulatory Intelligence ensuring timely reporting of ICSRs and Aggregate reports (DSUR, PSUR, PBRER) to regulatory and competent authorities.

Signal Detection and Assessment – Healthcare Professional review of individual ICSRs, line listings, aggregate and signal reports to proactively identify trends and signals.

EU-QPPV-support and oversight of client’s portfolio
Additional Services for Central Eastern Europe (CEE) include:

  • Provision of National Person Responsible for Pharmacovigilance/local PV contact person / Local Person for Pharmacovigilance (LPPV/ local QPPV) and Deputy; Assurance of 24/7 availability
  • Creation and maintenance of local PV systems, including local Pharmacovigilance System Master File (PSMF) and local SOPs
  • Managing of safety reports, including follow-up with reporters
  • Local implementation of additional Risk Minimization Measures (aRMMs)/ Risk Management Plans (RMPs) including Educational Materials and Direct Healthcare Professional Communication (DHCPs)
  • Writing Safety Data Exchange Agreements (SDEAs)
  • PV training for local affiliates and/ or distributor’s/ partner staff
  • Handling of Regulatory Authority inspections, including CAPA preparation

For more information on August Research’s PV services, please contact:
Christina Hristova
Business Development