Brief · Use case · Pharmacovigilance

Signal Management Setup Plan.

LivePlan

Plan the setup of a safety signal management process before authorization, with owners, dependencies and the first move.

ObjectiveA working signal management process before authorization

ReaderPharmacovigilance lead

ExpertHead of Pharmacovigilance

Not askedUnpublished deadlines

LengthStandard

Signal Management Setup Plan is a ready-made use case for Pharmacovigilance. It ships under the Plan template.

For pharmacovigilance leads standing up a process. You get the objective and critical path, the milestones with exit criteria and one accountable owner each, the dependencies outside the safety team, what could derail it and the first move. Claims are cited or marked as gaps.

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The decision

What is the plan to set up a safety signal management process for a first product ahead of marketing authorization, from governance to the first signal review?

The steps of the plan

Signal management has a European standard with defined roles. The plan builds the process from that standard and keeps the company’s own choices separate from the requirements.

Step	What it involves	The clock or source
Set the governance	Define who is responsible for signal detection, validation, analysis and the decision on action, and the quality system that covers them.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}	EMA’s good pharmacovigilance practices, Module IX on signal management, revision 1, in effect from 22 November 2017.
Choose the methods	Decide which data sources and detection methods the company will use, drawing on consensus points to consider for quantitative signal detection.^{2CIOMS Working Group VIII. Practical Aspects of Signal Detection in Pharmacovigilance. Geneva: CIOMS, 2010.}	The CIOMS Working Group VIII report on practical aspects of signal detection.
Write the procedure	Document how a signal is validated, prioritized, analyzed and escalated, and how the decision is recorded.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}	Module IX’s requirements and guidance.
Run the first review	Hold a first signal review with the documented procedure, so the process is tested before the product is on the market.	The company’s own schedule; no external clock before authorization.

What the plan does

Requirements apart from guidance. GVP Module IX separates requirements, usually marked by the word “shall”, from guidance for implementation, marked by “should”. The plan sorts each step into one or the other, so the company knows what it must do and what it may choose.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

Statistical methods in their own place. Revision 1 moved the statistical aspects to an addendum. The plan treats the choice of statistical method as a separate decision with its own owner.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

A consensus reference. A CIOMS working group, formed in 2006 with senior scientists from regulators, industry and academia, produced consensus points to consider on quantitative signal detection, published in 2010. The plan uses it as a starting reference and notes the corrigendum to its formula for the information component.^{2CIOMS Working Group VIII. Practical Aspects of Signal Detection in Pharmacovigilance. Geneva: CIOMS, 2010.}

How it could fail. The pre-mortem probes the failures this plan invites: roles that are written but not staffed, a procedure that has never been run, a data source that is not available before launch, or a detection method chosen without a plan to interpret its flags.

Recommended length

Standard

One team runs the plan and the gates are few. Standard carries the sequence, the clocks you do not control, what could derail it and the first move in about 1,500 words.

You can pick another length on the form. The other two stay available.

Assumptions the plan checks

The plan states the assumptions its dates rest on and says which one would move the finish if it failed. Examples for this plan:

The company will have access to the data sources the procedure names on the first day after authorization.
The people named in the roles are in post and trained before the first review.
The current revision of Module IX is the one in force at authorization.

Standards, guidance and sources

European standard and consensus guidance

EMA, Guideline on good pharmacovigilance practices, Module IX: Signal management (Rev. 1), reference EMA/827661/2011.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}
CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance, 2010.^{2CIOMS Working Group VIII. Practical Aspects of Signal Detection in Pharmacovigilance. Geneva: CIOMS, 2010.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any role the plan names that is not yet staffed, any requirement that rests on a revision of the module the plan did not read, and any data source not yet available.

What arrives

The objective
The sequence
Gates and decisions
Who is needed
Dependencies and external clocks
What could derail it
The first move

What it will not do

It does not promise dates. Each duration is sourced or marked as an estimate, and an unpublished deadline is a gap.

It does not write the procedure or run the first review, and it does not replace the qualified person for pharmacovigilance.

It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.

It does not invent an agency’s deadlines. A deadline that is not published is a gap.

It does not run the plan. It gives an owner the first move and the criteria for the next gate.

References

[1] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017. Status and scope as given in EMA’s listing found by search; the module was not read in full. Check whether a newer revision exists.
[2] CIOMS Working Group VIII. Practical Aspects of Signal Detection in Pharmacovigilance. Geneva: CIOMS, 2010. Known from the CIOMS publication page and search excerpts; the report was not read. A corrigendum corrects the formula for the information component on page 54.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

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