Pharmacovigilance (PV Services)

~ EU Qualified person in Pharmacovigilance Services (QPPV) to Pharmaceutical and Biotech     Companies.

• ~ Signal Detection, Safety Evaluation and Issue Work Ups arising from signal detection.
• ~ Risk Management strategies including preparation of EU RMP/RiskMAPs/REMS/PIPs.
• ~ PSUR, PADER, ASR, DSUR, SBR Preparation and Review.
• ~ Responding to queries from regulatory authorities on Assessment Reports.
• ~ Post Marketing Surveillance (PMS).
• ~ Preparation of CCDS and SmPc for labelling.
• ~ Preparation and development of Clinical Protocol Safety section.
• ~ Analysis and Review of safety data arising from all phases of Clinical Trials.
• ~ Experts in Regulatory Services and Support related to Pharmacovigilance
      (Vol 9a; FDA Guidances etc).