Medicines – Pharmacovigilance

  • Developing Pharmacovigilance Systems (PSMF) and Standard Operating Procedures (SOPs)
  • Assisting in implementing the Risk Management System and adhering to Good Pharmacovigilance Practices (GVP)
  • Drafting Risk Management Plans
  • Conducting signal detection and evaluating benefit-risk profiles
  • Handling adverse reaction reporting (CIOMs) and subsequent follow-up
  • Conducting literature research and preparing corresponding reports
  • Compiling Periodic Safety Update Reports (PSUR)
  • Providing support to the local Qualified Person Responsible for Pharmacovigilance (QPPV)