Pharmacovigilance Support

Case Processing


Detailed case entry and follow-up Safety narrative writing  Individual Case Safety Reports (ICSRs)  Quality review and medical review

Literature Monitoring


Literature search for reports of adverse events (AEs)

Aggregate Reports


Risk Management REMS
Strategy (REMS) Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Adverse Drug Experience Report (PADER) Development Safety Update Report (PSUR/DSUR)

Pharmacovigilance Consulting


Signal Detection, Evaluation, and Management
Pharmacovigilance database
SOP and Procedural Document Development Development of PV System Master File (PSMF)or Detailed Description of Pharmacovigilance System (DDPS) Pharmacovigilance trainings