Pharmacovigilance Support

Pharmacovigilance Support

Our pharmacovigilance (PV) experts including experienced PV physicians, licenced Medical Doctors (MDs) in collaboration with our medical writing group, we provide high-quality complete package pharmacovigilance and regulatory affairs services to help the pharmaceutical industry make safe and effective healthcare products available in Sub-Saharan Africa. 

Our services include:

  • Setting up, host and maintenance of local pharmacovigilance safety database including local PSMF, local SOPs.
  • Development of Safety Management Plans
  • Preparation and submission of periodic safety update reports (PSURs), safety update reports (DSUR) 
  • Development of Medical Monitoring Plans
  • Development of Risk Management Plans
  • Medical coding of AEs and medications (MedDRA, WHO Drug Dictionary)
  • Serious Adverse Events (SAEs) and safety information review
  • Acting as the medical point of contact for Investigators and sites and medical consultations
  • Continuous medical support on eligibility, issues, or concerns
  • Causality assessment discussions
  • Provision of Local Persons for Pharmacovigilance with assurance of 24/7 availability where required.
  • End-to-end local and global literature safety surveillance activities
  • Handling of requests and inspections from local Competent Authorities
  • Development of Summaries of product characteristics (SPCs) and Package Leaflets (PL)
  • Package Leaflet Readability User Testing (RUT) or Bridging Reports
  • Regulatory compliance oversight

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