Clinical
Rebecca Beausang
March 31, 2026
To safeguard patients’ safety, after a medicine is approved in a country or region, biopharma companies must implement a pharmacovigilance system and follow the regulations for pharmacovigilance standards within that market or region. This includes providing pharmacovigilance training to the appropriate personnel. Pharmacovigilance refresher courses are an essential part of keeping personnel up-to-date and compliant.
Within large markets (and many others, too), regulatory bodies such as the FDA in the United States or EMA in the European Union have adopted a pharmacovigilance framework that is aligned with international Good Pharmacovigilance Practice (GVP) guidelines. That said, there are striking differences even between large markets in terms of what details appear when it comes to pharmacovigilance training, and what has been mandated as a “must” versus a recommendation.
Understanding how to approach pharmacovigilance training and how often to repeat it to remain compliant involves a degree of interpretation of the regulations and guidelines within each market.
This post will explain how to approach pharmacovigilance training in two of the biggest regional markets, the United States and the European Union, by looking at FDA and EMA guidelines on pharmacovigilance so that you can mitigate your risk and meet your obligations through continuous pharmacovigilance training.
The frequency of pharmacovigilance training for biopharma employees is not explicitly mandated by the FDA, and nor are the recipients.
Instead, it expects that biopharma companies with marketing approval for a medicinal product in the United States establish and maintain a robust pharmacovigilance surveillance system in line with GVP guidance. How they do this is left somewhat open to interpretation. Clearly, personnel must be trained to an “adequate” level to ensure compliance with FDA post-marketing surveillance expectations.
Pharmacovigilance personnel in the United States must receive up-to-date GVP training which includes guidance on post-marketing surveillance through MedWatch—the FDA’s safety information and adverse event reporting program. MedWatch plays a crucial part of post-marketing approval surveillance in the United States. Training should be repeated with sufficient frequency so that personnel can carry out their duties compliantly.
Regular GVP training in the United States should also include the FDA’s risk assessment approach to pharmacovigilance. The FDA can initiate a Risk Evaluation and Mitigation Strategy (REMS) at any time, to help ensure that the benefits of a medication outweigh the risks. This may happen if post-marketing surveillance detects a safety signal that is unexpected (i.e. it differs from the safety data collected during clinical trials).
To minimize falling foul of the FDA, all pharmacovigilance personnel need role-specific training that is regularly refreshed and documented for audits. In addition to teams directly involved in pharmacovigilance activities, most biopharma companies also provide documented GVP training to a wide range of personnel. External-facing roles in Clinical Development, Medical Affairs, Commercial & Sales, and Regulatory Affairs & Legal often receive continuous pharmacovigilance training.
When it comes to pharmacovigilance, the EMA holds a much broader oversight scope than the FDA, which includes all post-marketing authorization pharmacovigilance activities. GVP requirements in the European Union cover signal detection, interpretation, documentation and reporting, periodic safety updates (PSURs), risk management plans, inspections and audits and post-authorization safety studies.
In order to perform their duties compliantly, the EMA expects that pharmacovigilance personnel and other biopharma personnel with indirect involvement in pharmacovigilance activities receive “adequate” training. Personnel must be able to plan, implement and maintain pharmacovigilance systems in line with the necessary standards. The EMA specifically mentions that personnel within clinical trials, front line staff within Medical Affairs and Commercial roles, as well as Regulatory and Legal teams should also receive training.
However, like the FDA, the frequency of training that is deemed “adequate” is not detailed and is left open to interpretation.
Pharma companies must meet the pharmacovigilance requirements for all of the countries they operate in, making global GVP training a necessity for compliance. This means that if a company is operating in both the United States and European Union, for example, both the FDA and EMA standards must be met. The implications of this are that relevant personnel must have in-depth understanding of how GVP principles are translated into law by local regulatory bodies.
The consequences of noncompliance in a single market can be severe and include fines, product recalls, as well as damage to a company’s reputation.
Patient safety, public relations and company reputation rely on an effective pharmacovigilance system. Regular pharmacovigilance training ensures pharmacovigilance standards are high, which safeguards patients and builds trust with the public and healthcare community.
When it comes to regulators, noncompliance with pharmacovigilance rules and guidance starts with unawareness or gaps in knowledge about what is expected. Regular training avoids noncompliance by ensuring that everyone knows what the regulators’ expectations are.
During audit, or at times of increased scrutiny such as if the FDA initiated a REMS program to reevaluate a medicines’ risk to benefit ratio, having documented, regular, accredited pharmacovigilance training goes a long way with regulators. It demonstrates that an appropriate level of due diligence has been in place since marketing approval/authorization was received.
Although the FDA and EMA don’t specify how often pharmacovigilance training should be completed by biopharma personnel most biopharma companies adopt a risk-minimization stance when interpreting this.
To minimize the risk of falling short of regulators’ expectations, biopharma companies often provide annual, accredited GVP training to personnel, which is then well documented in preparation for an audit.
In other words, personnel with direct or indirect involvement in pharmacovigilance should receive annual training that encompasses both a foundation-level knowledge in pharmacovigilance (if appropriate), such as an introduction to GVP or a global awareness of pharmacovigilance, as well as detailed training on how to perform to their specific pharmacovigilance duties.
We at GxP Training recommend annual pharmacovigilance refresher courses for both pharmacovigilance teams and personnel involved in external-facing activities within Clinical Development, Commercial and Medical Affairs.
For example, annual completion of two certified introduction and awareness GVP courses from our catalog, which are fully aligned with auditors’ expectations:
Introduction to Good Pharmacovigilance Practice: Gain a solid foundation in GVP principles and how they follow marketing approval in the US or marketing authorization in the EU. This course introduces key concepts of pharmacovigilance requirements, including how adverse effects are detected, recorded, assessed, understood, reported, and prevented.
Global Pharmacovigilance Awareness: Learn the origin, scope, and purpose of pharmacovigilance; understand and compare pharmacovigilance systems and case processing; and discover how to achieve global pharmacovigilance awareness.
All our courses are built to deliver trusted certification, with the following key benefits:
