Pharmacovigilance

GSS Pharma Private Limited provides end-to-end Pharmacovigilance services to Pharmaceutical companies all over the globe. Our team consists of highly qualified and skilled experts who strive hard to deliver complaint pharmacovigilance services to the companies with an uncompromised quality objective.

Our pharmacovigilance services include reporting of adverse events in Individual Case Study Reports (ICSR) by following multiple steps including case triage, booking in, case processing, medical review, quality review and then submitting to the health authorities (HA). Also our services include generation of expedited and aggregate reports in the form of Periodic Safety Updated Reports (PSUR), Monitoring of Medical Literature (MLM), Signal Detection and Evaluation, Risk Management Plans (RMP), etc.

  • Pharmacovigilance System Management
  • Risk Management
  • ICSR Case Management
  • Worldwide Scientific Literature Management
  • PSUR/PBRER/Aggregate reports
  • Signal Detection and Management
  • Benefit-Risk evaluation for Products
  • Product Information Updates
  • Pharmacovigilance System Management: EU Pharmacovigilance System Master File, Summary of Pharmacovigilance System and Procedural documents
  • Risk Management: Risk Management Plan, Risk Evaluation and Mitigation Strategies, Annual Safety Reviews
  • ICSR Case Management: Receiving, Processing and Submission of Individual Case Safety Reports
  • Worldwide Scientific Literature Management: Screening and Processing of Literature Reports
  • PSUR/PBRER/Aggregate Reports: Preparation, Evaluation and Submission
  • Product Information Updates: SmPC & PIL, Prescribing Information & Medication Guides
  • European Union Data Submission on Medicines: Extended EudraVigilance Medical Product Dictionary-XEVMPD Maintenance and EVWEB Updates