Pharmacovigilance signal detection is one of the most critical responsibilities within Pharmcontrol’s safety system. Identifying potential risks to patient health at the earliest possible stage allows us to prevent harm and support regulatory decision-making. Safety signals—early indicators of possible adverse effects linked to medicinal products—require timely recognition and expert analysis.

Our approach to signal detection combines data from global reporting systems, established scientific methodologies, and the clinical expertise of our team. Through continuous pharmacovigilance monitoring and evaluation, we help ensure that emerging risks are identified promptly and managed according to both national and international safety standards.

What Is a Safety Signal?

A safety signal refers to new or changing information suggesting a potential link between a medicinal product and an adverse event. According to the World Health Organization (WHO), a signal usually arises from multiple reports of a suspected side effect and represents a hypothesis that justifies further investigation.

It’s important to note that a signal does not prove a causal relationship. Rather, it indicates the need for deeper analysis and clinical evaluation to determine whether regulatory action is warranted.

Signals can refer to:

• A newly identified adverse effect

• A change in frequency or severity of a known reaction

• A potential mechanism of harm

• At-risk patient groups or dose ranges

• Unexpected lack of efficacy

How We Detect Signals

1. Data Collection and Screening

Pharmcontrol regularly reviews spontaneous reports submitted by healthcare professionals, pharmaceutical companies, and patients worldwide. These reports are collected in our proprietary BaseControl database, which serves as the foundation for continuous safety signal monitoring.

2. Statistical and Clinical Assessment

Our signal detection process combines automated screening tools with expert medical review. We use disproportionality analysis, such as Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR), to identify unusual patterns in adverse event reporting.

3. Literature and Regulatory Monitoring

We systematically review scientific literature and safety communications from global regulatory agencies. This helps us cross-reference and validate potential signals and avoid duplication of signal work performed by other organizations.

4. Prioritization and Clinical Evaluation

Potential safety signals are evaluated by our internal signal team and, when needed, in consultation with external experts. Evaluation includes:

• Reviewing product information and known risks

• Excluding alternative causes

• Applying clinical criteria such as the Bradford Hill principles for causation

• Assessing public health relevance and severity

What Happens After a Signal Is Identified?

If a signal is considered credible, it is formally documented and assessed. Depending on its impact, we may:

• Recommend updates to product safety information

• Notify national regulatory authorities

• Communicate with healthcare professionals or the marketing authorization holder

• Submit the signal to WHO or publish findings through public channels

Pharmcontrol ensures that safety signals are not only detected but also communicated responsibly and transparently.