Pharmacovigilance : An overview

Pharmacovigilance : An overview

Pharmacovigilance is an important aspect of the pharmaceutical industry that aims to ensure the safety and efficacy of medications. It involves the monitoring, assessment, and prevention of adverse effects or any other drug-related problems.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a critical role in the safety and effectiveness of drugs used in the treatment of diseases.

Importance of Pharmacovigilance

Pharmacovigilance is essential for identifying potential adverse reactions to drugs and taking action to prevent them. By detecting and assessing the safety of drugs, pharmacovigilance helps to ensure that patients receive effective and safe treatments for their conditions. It also helps to identify drug interactions and issues related to medication errors.

The Pharmacovigilance Process

The pharmacovigilance process includes the collection, analysis, and reporting of adverse drug reactions (ADRs). The collection of data is usually done through spontaneous reporting, where healthcare professionals or patients report ADRs to regulatory authorities. The data is then analyzed and evaluated by experts to determine if the drug is safe to use.

The Role of Regulatory Authorities in Pharmacovigilance

Regulatory authorities play a vital role in pharmaco-vigilance. They are responsible for ensuring that drugs are safe and effective for use by patients. They review data from clinical trials and monitor the safety of drugs once they are on the market. The regulatory authorities also enforce regulations and guidelines to ensure that pharmaceutical companies follow good pharmacovigilance practices.

Challenges in Pharmacovigilance

Pharmacovigilance faces several challenges, including under-reporting of ADRs, lack of access to data, and difficulty in identifying rare ADRs. Additionally, the emergence of new technologies, such as social media, has made it challenging to monitor and analyze drug safety information effectively.

Future of Pharmacovigilance

The future of pharmacovigilance is promising, with the emergence of new technologies and the increasing focus on patient-centered care. Big data analytics, artificial intelligence, and machine learning are expected to play a significant role in pharmacovigilance. These technologies can help to identify ADRs more quickly and accurately, improving patient safety and reducing the time and costs associated with pharmacovigilance.

Capabilities in requirement

  • Single point of contact for the entire range of safety services including ICSR, aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US agent services, signal detection & evaluation, database migration, adverse event reconciliation, local affiliate services, and any other region-specific pharmacovigilance consulting services
  • Initial kick-off to submissions to the HA and handling/addressing HA queries
  • In-depth safety knowledge perfectly integrated with required IT capabilities
  • Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control, and submission
  • Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA’s AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac, etc.
  • Expertise in writing aggregate safety documents as per various Health Authorities and submission requirements such as Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country-specific reports, etc.
  • Expertise in setting up PV systems and processes such as PV database evaluation, PV database validation, harmonization, writing SOPs, and training employees as per the local Regulatory requirements in various geographies
  • Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities through the pharmacovigilance consulting services
  • Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
  • Experience in tracking safety variations and PV System Master File (PSMF) compliance
  • Defined processes of thorough scientific, medical, editorial, and quality control review
  • Timely delivery with the highest standard of quality
  • Expert program and project management support to maintain compliance


In conclusion, pharmacovigilance is a critical aspect of the pharmaceutical industry, ensuring that drugs are safe and effective for patients. Regulatory authorities, healthcare professionals, and pharmaceutical companies must work together to ensure that pharmacovigilance is done effectively. With the emergence of new technologies, the future of pharmaco-vigilance looks promising, with the potential to improve patient safety and reduce the costs and time associated with drug development and monitoring.