Pharmacovigilance (PV): An Essential Pillar of Public Health and Drug Development

Dr Suzanne Foncin

Scientific Director, Safety Evaluation and Risk Management, GSK

In her engaging presentation, Dr Suzanne Foncin demystified the field of Pharmacovigilance (PV), underlining its critical role in safeguarding public health and maintaining trust in the pharmaceutical industry.

PV, also known as drug safety, or more recently as patient safety, is defined by the World Health Organisation as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

PV’s Purpose and Importance

PV’s primary goals are to monitor medicines across their lifecycle and enhance patient outcomes by identifying and minimising risks.

While clinical trials provide valuable safety data, many rare or long-term adverse effects only emerge once a drug reaches broader populations.

Hence, PV continues long after a medicine enters the market, ensuring the benefit-risk balance remains favourable over time.

Key Concepts in Pharmacovigilance

Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
These are the basic units in PV and are at the core of drug safety:

Adverse Events (AEs): Any undesirable medical events during treatment, regardless of causality
Adverse Drug Reactions (ADRs): Unintended and harmful effects directly linked to the drug when used at normal doses

Establishing causality is crucial, and information is sourced globally from:

Spontaneous reporting systems (e.g., UK’s Yellow Card, US FDA’s FAERS)
Clinical trials
Electronic health records
Literature reviews
Epidemiological studies

Signal Detection

One of PV’s key processes is signal detection—the identification of new or under-recognised drug-event associations.

Signals can arise from multiple data sources and require a structured analysis pathway, including:

Validation
Expert assessment

If a signal points to a new risk, it may lead to regulatory actions, such as:

Label changes
Enhanced monitoring

Risk Management
Dr Foncin also elaborated on risk management, which involves:

Assessing
Characterising
Mitigating known or potential risks

This is captured through Risk Management Plans (RMPs), which:

Guide further studies
Outline how to prevent recurrence of adverse outcomes

Risk Minimisation Measures (RMM) may be:

Routine (e.g., product leaflets)
Additional (e.g., educational materials, patient booklets, pregnancy prevention programmes)

The Benefit-Risk Balance
The benefit-risk balance remains at the heart of PV.

While no drug is without risk, transparent communication with:

Regulators
Healthcare professionals
Patients

...enables informed decisions and ongoing safety evaluation.

This cyclical process incorporates stakeholder feedback and continuously improves product safety.

A Real-World Example

Dr Foncin illustrated PV’s real-world impact with the case of thalidomide, a drug withdrawn due to its teratogenic effects, but reintroduced in 2008 for multiple myeloma with stringent risk controls in place, showcasing how PV can enable the safe re-use of previously harmful medicines under strict frameworks.

Career Opportunities in PV

Dr Foncin highlighted PV as a rewarding and impactful career in medical communications.

Career paths include roles such as:

Drug safety specialist
Signal detection analyst
Medical reviewer
Risk management lead
Scientific writer

Scientific writing, in particular, spans critical documentation like:

Periodic Safety Update Reports (PSURs)
Risk Management Plans (RMPs)

...where clarity, accuracy, and regulatory insight are essential.

Final Thoughts

In conclusion, Dr Foncin emphasised again that PV is a globally coordinated, scientifically robust, and highly dynamic discipline. It ensures medicines are not only effective but remain safe for the people who rely on them - making it both an intellectually and ethically rewarding field for medical communication professionals.

Every day she wakes up with purpose – she knows her work makes a huge difference!