Pharmacovigilance (PV)

Pharmacovigilance (PV)

Pharmacovigilance (PV) is commonly referred to as drug safety because it involves monitoring and assessing the safety and efficacy of medications throughout their lifecycle, from pre-marketing clinical trials to post-marketing surveillance. It involves collaboration among pharmaceutical companies, healthcare professionals, regulatory authorities, and patients to enhance the understanding of medication safety and optimize patient care. The primary objectives of PV are to detect, assess, understand, and prevent adverse effects or any other drug-related problems.

We have staff with practical knowledge of handling and administering both standard and custom safety databases. Our team has established procedures for in-depth editorial, quality control, scientific, and medical review. Delivery on schedule and to the highest possible standard. Support for expert programme and project management to uphold compliance.

Pharmacovigilance (PV)
  • Individual Case Safety Report (ICSR)
  • Literature Evaluation
  • Aggregate Report
  • Risk Management Plan
  • Signal Detection
  • Regulatory Submission

Individual Case Safety Report (ICSR)

Aggregate Report

Signal Detection

Risk Management Plan