Pharmacovigilance services in South Korea

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in South Korea, explore DDReg’s pharmacovigilance services in South Korea to ensure drug safety, patient protection, and regulatory compliance. From adverse drug reaction reporting to comprehensive post-marketing surveillance, the right PV partner shapes everything from signal detection and risk management plans to safety reporting and maintaining market authorization.

As a leading pharmacovigilance provider in South Korea, DDReg combines global expertise with deep local knowledge. We understand the nuances of pharmacovigilance for clinical trials in South Korea, signal detection, aggregate reporting, and compliance with MFDS and KIDS requirements. Our services include tailored safety management plans, global safety database pharmacovigilance, and medical device pharmacovigilance in South Korea.

DDReg is a top-tier pharmacovigilance consultant in South Korea and among reputable pharmacovigilance consulting services firms in South Korea. We support clinical safety and pharmacovigilance in South Korea, signal management in South Korea, provide pharmacovigilance medical writing in South Korea, and meet the needs of marketing authorization holder pharmacovigilance in South Korea, including drug safety and risk management in South Korea and assistance with medical device pharmacovigilance in South Korea.

• + ICSR Processing & Submission
  • Triage and follow-up of ICSRs, including SUSARs
  • Processing in E2B(R3)-compliant databases with WHO DD and MedDRA integration
  • Quality checks, medical reviews, timely submissions, monitoring, tracking, and customer reconciliation
• + Risk Management Plan (RMP)
  • Draft, review, and maintain RMPs/REMS, support submission
  • Develop customized procedures for classification of safety risks and safety management plan pharmacovigilance in South Korea
  • Implement Post-Authorization Safety Studies (PASS ): educational materials, observational studies, questionnaires
  • Communicate risks effectively via Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • PSURs, PBRERs, DSURs, and Annual Safety Reports (ASRs)
• + Signal Management
  • Detect new safety signals via KAERS, literature, aggregate reporting, and agency websites
  • Use in-house tools and databases to track signals
  • Review signals, perform label update analyses, provide recommendations, and prepare Signal Management Trackers and Annual Reports
• + Local Pharmacovigilance Services in South Africa
  • Review PSMF, SDEAs , commercial partner agreements, PV SOPs
  • Monthly data reconciliation and compliance metrics
  • Medical review of signals, conduct Signal Surveillance meetings
• + PV Quality Management & Compliance
  • Compliance review against PV guidelines, regulations, SDEAs, SOPs
  • Perform audits, mock audits, and gap assessments to prepare for MFDS and KIDS inspections
  • Provide training for PV safety audits, inspections, and site staff readiness