Scientific Writing in Pharmacovigilance

Introduction

Scientific writing is one of the most important professional skills in pharmacovigilance. Every regulatory document prepared by a Marketing Authorisation Holder (MAH), Contract Research Organisation (CRO) or regulatory authority depends upon the author's ability to communicate scientific evidence accurately, objectively and transparently.

Unlike academic publications, pharmacovigilance documents are written primarily to support regulatory decision-making. Their purpose is not to persuade the reader but to present available evidence fairly, explain the scientific reasoning applied during evaluation and allow independent reviewers to understand how conclusions were reached.

Whether preparing a Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Risk Management Plan (RMP), signal assessment, regulatory response or inspection briefing document, the same principles of scientific writing apply.

This article describes those principles.

Why Scientific Writing Matters

Poor scientific writing may obscure sound scientific reasoning.

Conversely, excellent writing cannot compensate for weak scientific evidence.

The objective is therefore to communicate complex scientific evaluations in a manner that is:

• accurate;

• objective;

• balanced;

• transparent;

• reproducible;

• proportionate to the available evidence.

Scientific writing should help readers understand both what is known and what remains uncertain.

Scientific Writing Is Scientific Thinking

Writing should never be viewed as the final administrative step after completing an evaluation.

Experienced aggregate physicians use writing to test their own reasoning.

If the scientific argument cannot be explained clearly, this frequently indicates that further evaluation is required.

Consequently, writing and scientific thinking should evolve together throughout preparation of the document rather than occurring as separate activities.

Regulatory Expectations

Regulatory authorities expect scientific writing to demonstrate:

• objective evaluation of evidence;

• balanced discussion of supporting and contradictory findings;

• appropriate acknowledgement of uncertainty;

• consistency between evidence and conclusions;

• traceability of scientific reasoning;

• appropriate regulatory terminology.

The quality of scientific writing therefore influences not only readability but also regulatory confidence in the underlying evaluation.

Writing Principle

Good scientific writing does not make weak evidence appear stronger.

Good scientific writing makes the strength—and limitations—of the available evidence easy to understand.

The Ten Principles of Scientific Writing

Although pharmacovigilance documents vary considerably in their purpose and regulatory requirements, experienced authors consistently apply a small number of fundamental scientific writing principles. These principles improve clarity, strengthen scientific credibility and allow regulatory reviewers to understand not only the conclusions reached but also the reasoning that supports them.

The principles described below apply equally to aggregate reports, risk management plans, signal evaluations, responses to regulatory questions, inspection documentation and routine medical assessments.

Principle 1 — Write from Evidence, Not Opinion

Scientific writing should always be based upon objective evidence rather than personal belief or organisational preference.

Every important conclusion should be supported by one or more identifiable sources of evidence.

These may include:

• Individual Case Safety Reports (ICSRs);

• clinical trial data;

• post-authorisation safety studies (PASS);

• pharmacoepidemiological studies;

• published scientific literature;

• regulatory assessments;

• mechanistic or pharmacological evidence where appropriate.

Authors should avoid unsupported statements, assumptions and speculative conclusions.

Where evidence is limited, the limitations should be acknowledged explicitly rather than concealed through confident language.

Scientific Writing Principle #1

Every important conclusion should be traceable to objective evidence.

Principle 2 — Separate Observation from Interpretation

One of the most common weaknesses in pharmacovigilance writing is failure to distinguish factual observations from scientific interpretation.

For example:

Observation

"Forty-two cases of acute pancreatitis were identified during the reporting interval."

Interpretation

"The cumulative evidence suggests that the observed cases remain consistent with the recognised safety profile and do not indicate an increased reporting frequency after adjustment for patient exposure."

Readers should never be expected to infer where objective evidence ends and medical judgement begins.

Making this distinction explicit improves transparency and strengthens scientific credibility.

Scientific Writing Principle #2

Describe what was observed before explaining what it means.

Principle 3 — Separate Interpretation from Regulatory Action

Scientific interpretation and regulatory decision-making are closely related but represent different stages of pharmacovigilance.

Scientific interpretation explains what the available evidence demonstrates.

Regulatory decisions determine whether that evidence requires changes to product information, additional pharmacovigilance activities, risk minimisation measures or other regulatory actions.

Authors should avoid presenting regulatory actions as though they themselves constitute scientific evidence.

Similarly, scientific conclusions should not be influenced by anticipated regulatory outcomes.

Scientific Writing Principle #3

Scientific evidence supports regulatory decisions. Regulatory decisions do not create scientific evidence.

Principle 4 — Communicate Uncertainty Honestly

Uncertainty is an inherent feature of pharmacovigilance.

The objective of scientific writing is not to eliminate uncertainty but to communicate it accurately.

Examples include:

• limited patient exposure;

• rare adverse reactions;

• conflicting evidence;

• ongoing studies;

• incomplete follow-up;

• under-represented patient populations.

Authors should avoid language that exaggerates certainty beyond that supported by the available evidence.

Equally, they should avoid excessive caution when the evidence is robust.

The degree of confidence expressed should reflect the quality, consistency and completeness of the available data.

Scientific Writing Principle #4

Express confidence in proportion to the available evidence.

Principle 5 — Present Contradictory Evidence Fairly

Scientific credibility is strengthened when authors discuss evidence that both supports and challenges their conclusions.

Regulatory authorities expect balanced scientific evaluation rather than selective presentation of favourable findings.

Contradictory evidence may include:

• epidemiological studies showing no increased risk;

• clinical trial findings differing from spontaneous reporting;

• conflicting published literature;

• alternative biological explanations;

• differing regulatory assessments;

• studies with inconsistent conclusions.

The objective is not to resolve every disagreement but to explain how the totality of evidence influenced the final scientific judgement.

Ignoring contradictory evidence weakens both scientific credibility and regulatory confidence.

Scientific Writing Principle #5

A balanced discussion of conflicting evidence strengthens rather than weakens scientific conclusions.

Principle 6 — Explain Your Reasoning, Not Only Your Conclusion

Scientific conclusions should never appear as unsupported statements.

Readers should understand:

• what evidence was considered;

• why particular evidence carried greater weight;

• how alternative explanations were evaluated;

• why competing interpretations were rejected;

• why the final conclusion was considered appropriate.

This approach allows independent reviewers to follow the author's reasoning even when they may not ultimately reach the same conclusion.

Transparency of reasoning is one of the defining characteristics of high-quality regulatory writing.

Scientific Writing Principle #6

Readers should be able to understand how you reached your conclusion—not simply what your conclusion was.

Principle 7 — Use Precise Scientific Language

Scientific writing depends upon precision.

Terms such as:

• "caused";

• "proved";

• "safe";

• "harmless";

• "confirmed";

should be used only where justified by the available evidence and the regulatory context.

Similarly, vague expressions such as:

• "appears significant";

• "many cases";

• "probably";

• "very likely";

should be avoided unless their meaning is explained clearly.

Authors should select language that accurately reflects:

• the quality of evidence;

• the degree of uncertainty;

• the strength of the scientific conclusion.

Consistency of terminology throughout the document is equally important.

Scientific Writing Principle #7

Choose language that reflects the evidence—not the author's confidence.

Principle 8 — Write in Proportion to the Importance of the Evidence

Not every observation deserves equal discussion.

Scientific writing should remain proportionate to:

• the clinical importance of the issue;

• the quality of the evidence;

• the potential regulatory impact;

• the degree of uncertainty;

• the effect on the benefit-risk balance.

For example, a validated signal with potential implications for patient safety may require extensive discussion.

Conversely, routine findings confirming previous conclusions may require only a concise update.

Proportionate writing improves readability and helps reviewers focus on the most important scientific issues.

Scientific Writing Principle #8

The depth of discussion should reflect the importance of the scientific question rather than the volume of available data.

Principle 9 — Maintain Internal Consistency

Scientific documents should read as a single coherent evaluation rather than independent sections written by different authors.

Authors should ensure consistency in:

• terminology;

• interpretation of evidence;

• description of risks;

• benefit-risk conclusions;

• regulatory actions;

• scientific uncertainty.

Internal inconsistencies reduce confidence in the report and often prompt additional regulatory questions.

Consistency should therefore be verified during final medical review before submission.

Scientific Writing Principle #9

Every section should support the same scientific narrative unless the purpose is to explain why that narrative has changed.

Principle 10 — Make Every Conclusion Traceable

Scientific conclusions should always be traceable.

An experienced reviewer should be able to identify:

• the evidence supporting each conclusion;

• the reasoning linking evidence to interpretation;

• the interpretation supporting regulatory decisions;

• the regulatory decisions leading to operational actions.

Traceability improves transparency, facilitates regulatory review and supports inspection readiness.

It also enables future reviewers to understand how scientific thinking evolved over successive assessments.

Scientific Writing Principle #10

Every conclusion should have an identifiable chain of evidence, reasoning and scientific judgement.

The Scientific Writing Workflow

The ten principles are not independent rules. They operate together as a structured method of scientific communication.

A useful mental model is:

Evidence

↓

Observation

↓

Interpretation

↓

Scientific Conclusion

↓

Benefit-Risk Evaluation

↓

Regulatory Decision

↓

Operational Action

↓

Scientific Communication

Each stage should be supported by the preceding stage.

Skipping stages often results in unsupported conclusions, inconsistent reasoning or inappropriate regulatory recommendations.

This workflow applies equally to an Individual Case Safety Report medical assessment, a signal evaluation, a Risk Management Plan, a PBRER or a response to a regulatory authority.

Writing Insight

Experienced pharmacovigilance professionals rarely begin by asking, "How should I write this?"

They begin by asking, "Can I explain my scientific reasoning clearly enough that another experienced reviewer would understand—and, if necessary, challenge—every important conclusion?"

Clear scientific writing is the natural consequence of clear scientific thinking.

The Evolution of a Pharmacovigilance Writer

Scientific writing develops progressively throughout a pharmacovigilance professional's career. The greatest improvements usually result not from learning additional writing techniques but from developing deeper scientific judgement.

As experience increases, authors become less concerned with producing longer documents and more concerned with producing clearer scientific reasoning.

The following stages illustrate this progression.

Stage 1 — Recording Information

Early in their careers, pharmacovigilance professionals focus primarily on documenting information accurately.

Typical questions include:

• What information should be included?

• Which template should I follow?

• Which regulations apply?

The emphasis is on completeness and compliance.

Although these skills are essential, the document frequently becomes descriptive rather than analytical.

Stage 2 — Interpreting Evidence

As experience develops, authors begin moving beyond description.

Instead of merely reporting observations, they ask:

• What does this evidence mean?

• Does it support an existing hypothesis?

• Are there alternative explanations?

Scientific interpretation gradually becomes more important than documentation alone.

Stage 3 — Evaluating Evidence

Experienced reviewers recognise that evidence varies considerably in quality.

They begin asking:

• Which evidence is most reliable?

• Which findings deserve greater weight?

• Are the observed associations biologically plausible?

• How much uncertainty remains?

Evaluation gradually replaces description as the central activity.

Stage 4 — Integrating Knowledge

Senior aggregate physicians rarely evaluate evidence in isolation.

Instead, they integrate information from multiple independent sources, including:

• Individual Case Safety Reports;

• clinical trials;

• post-authorisation safety studies;

• pharmacoepidemiological investigations;

• scientific literature;

• regulatory assessments;

• pharmacological mechanisms.

The objective is no longer simply to analyse individual datasets but to determine what the cumulative evidence demonstrates.

Stage 5 — Scientific Leadership

The most experienced pharmacovigilance professionals begin asking different questions altogether.

Examples include:

• Would another experienced reviewer reach the same conclusion?

• Have I considered evidence that challenges my interpretation?

• Have I communicated uncertainty appropriately?

• Can every important conclusion be traced to objective evidence?

• Would this reasoning remain defensible during regulatory assessment or inspection?

At this stage, scientific writing becomes an extension of scientific leadership rather than an administrative activity.

The author is no longer simply preparing a regulatory document but helping an organisation reach evidence-based decisions affecting patient safety.

Characteristics of Expert Scientific Writing

Although writing styles differ between organisations and individuals, experienced pharmacovigilance authors generally share several characteristics.

They:

• distinguish observations from interpretation;

• distinguish interpretation from regulatory action;

• communicate uncertainty honestly;

• acknowledge contradictory evidence;

• explain their reasoning transparently;

• write proportionately to the available evidence;

• maintain consistency throughout the document;

• ensure that every important conclusion remains traceable to supporting evidence.

These characteristics consistently improve the quality, credibility and regulatory acceptability of pharmacovigilance documents.

Continuous Improvement

Scientific writing is not mastered after completing a training course or learning a particular report template.

It develops through continuous exposure to new evidence, multidisciplinary discussion, regulatory feedback, peer review and reflective practice.

Experienced authors regularly revisit previous conclusions in light of emerging evidence and remain willing to modify both their scientific understanding and their writing style.

The objective is not simply to produce compliant documents but to communicate scientific reasoning with increasing clarity, precision and intellectual honesty throughout a professional career.

Professional Reflection

The best pharmacovigilance writers are recognised not because they write the longest reports or use the most sophisticated language, but because they make complex scientific reasoning understandable, transparent and reproducible.

Key Takeaways

Scientific writing is one of the core professional competencies in pharmacovigilance.

Effective scientific writing communicates evidence accurately, distinguishes observations from interpretation, explains scientific reasoning transparently and expresses conclusions in proportion to the available evidence.

These principles apply consistently across Individual Case Safety Reports, aggregate reports, Risk Management Plans, regulatory responses, inspection documentation and scientific publications.

Ultimately, excellent pharmacovigilance writing reflects excellent pharmacovigilance thinking.

Continue Reading

• [[how-to-write-aggregate-safety-reports]]

• [[signal-evaluation-methodology]]

• [[benefit-risk-evaluation-in-pharmacovigilance]]

• [[causality-assessment-in-pharmacovigilance]]

• [[pharmacoepidemiology-for-pharmacovigilance-professionals]]

• [[medical-review-of-individual-case-safety-reports]]

• [[writing-the-integrated-benefit-risk-evaluation-section-in-a-pbrer]]

References

Regulatory Guidance

1. ICH E2C(R2): Periodic Benefit-Risk Evaluation Report.

2. EMA Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Report.

3. EMA Good Pharmacovigilance Practices (GVP) Module IX – Signal Management.

4. EMA Good Pharmacovigilance Practices (GVP) Module V – Risk Management Systems.

5. Commission Implementing Regulation (EU) No 520/2012.

International Guidance

1. CIOMS VIII. Practical Aspects of Signal Detection in Pharmacovigilance.

2. CIOMS Working Group reports on benefit-risk assessment and aggregate safety evaluation.

3. ENCePP Guide on Methodological Standards in Pharmacoepidemiology.

4. ISPE Good Pharmacoepidemiology Practices.

Scientific Literature

1. Aronson JK, Hauben M. Signal detection in pharmacovigilance: scientific foundations and evolving methodologies.

2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management.

3. Selected peer-reviewed publications relating to scientific reasoning, causal inference, medical writing and regulatory decision-making in pharmacovigilance.