Drug Safety

  • Development/writing/review of PV regulatory submission documents including: Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance system (SPS), periodic safety reports (PSUR, DSUR), Risk Management Plans, post-authorisation safety and efficacy studies (PASS/PAES) protocols, medical review of SAEs, literature monitoring, documents concerning safety related referral procedures and other safety concerning reports
  • Fulfilling the role of EU-QPVP
  • Establishing a compliant Pharmaceutical and/or Medical Device Vigilance System from start-up
  • Pharmacovigilance trainings for beginners and advanced including on regulatory inspection preparedness and writing of PV documents

Maria Bomer