The Evolving Role of Quality Assurance in Pharmacovigilance: Leading proactive risk-based approach in Patient Safety

In the wake of the MHRA’s safety data review leading to the recall of pholcodine-containing medicines in the UK*, a burning question came to my mind: Could proactive Quality Assurance (QA) practices, including early signal detection and collaboration with healthcare providers for patient insights, have prevented the need for such widespread recalls and averted widespread issues?

In the ever-evolving pharma landscape, the role of Quality Assurance (QA) in Pharmacovigilance has undergone significant transformations, becoming a linchpin in ensuring patient safety and regulatory compliance.

Traditionally, QA in Pharmacovigilance focused on post-marketing surveillance, ensuring the accuracy and completeness of adverse event reporting. However, with advancements in technology and a shift toward a more patient-centric approach, QA’s role has expanded to encompass a broader and more proactive scope.

One notable evolution lies in the adoption of risk-based approaches. QA teams now leverage data analytics and artificial intelligence to identify potential risks early in the drug development process, allowing for timely intervention and mitigation. This shift towards a predictive model enhances the overall quality of pharmacovigilance activities.

Integration of automated tools streamlines data collection, and analysis not only enhances the accuracy of adverse event assessments but also allows QA professionals to focus on higher-value tasks, such as strategic planning and continuous improvement initiatives.

Real-world examples like the “implementation of advanced data analytics to predict potential safety issues, enabling proactive risk management or “embracing automation to enhance the efficiency of its pharmacovigilance activities, leading to improved compliance and faster response times prove that this is an evolving paradigm.

As global collaborations become more commonplace, QA in Pharmacovigilance plays a vital role in harmonizing processes across diverse regulatory landscapes. Said that multinationals are establishing global quality standards that ensure consistency in pharmacovigilance practices across all regions.

In conclusion, the evolving role of QA in Pharmacovigilance is marked by a proactive and technology- driven approach. By embracing risk-based strategies, automation, and global standardization, QA is at the forefront of safeguarding patient well-being and maintaining the highest standards of drug safety and efficacy.

The details of the evolving role of Quality Assurance in Pharmacovigilance will be discussed at our upcoming DRUG SAFETY SYMPOSIUM 2024 happening on February 14 – 15, 2024.

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Vrushali Negandhi
Head: Production and Research
Eminence Group


  1. Highlighted a very relevant and pressing challenge of the industry. Indeed PV tools need upgradation and better collaboration with QA and RG.

  2. Highlighted a very relevant and pressing challenge of the industry. Indeed PV tools need upgradation and better collaboration with QA and RG.

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