Signal Evaluator
Scientific · Industry · Signal Management
Drives signal detection and evaluation activities and educates stakeholders on signal management methodologies and tools.
Also known as: Signal Scientist, Safety Signal Assessor
This competency standard is a working draft prepared for reviewand is not yet an official GPPC standard. Content is derived from the role’s job description and established pharmacovigilance practice, and is subject to change.
Job description
- Responsible for educating stakeholders on the use of state-of-the-art signal detection methodologies, signal management processes and tools.
- Provide strategic support, training, and expertise for the development and maintenance of excellence in the Signal Management component of activities and work in close collaboration with other divisions.
- Develop and conduct signal detection activities, adverse event trending analysis and prepare signal detection and trending reports.
- Perform and oversee routine signal detection activities (literature review, individual case awareness and aggregate data review) to identify, assess and escalate signals appropriately.
- Author and contribute to relevant regulatory documents (e.g., PSURs, renewal documents, RMPs, submission documents) according to agreed timelines and processes.
- Develop and deliver relevant training.
Overall required level: Intermediate.The Signal Evaluator is expected to hold intermediate-to-expert knowledge of signal detection and management methodologies, aggregate data review and the regulatory documents that signals inform.
Prerequisites
Mandatory prerequisites
- →University degree in a life-science, pharmacy or medical discipline
- →Experience in signal detection or safety science
Recommendations
- →Working proficiency in English
- →Familiarity with disproportionality analysis tools
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance principles and GVP Module IX (Signal management) | Expert |
| Sources of safety data (spontaneous, literature, aggregate) | Expert |
| Benefit–risk concepts | Intermediate |
Role-Specific Knowledge
| Topic | Level |
|---|---|
| Signal detection methodologies and disproportionality analysis | Expert |
| Signal validation, assessment and escalation | Expert |
| Adverse event trending and reporting | Intermediate |
| Aggregate reports (PSUR/PBRER) and RMP contributions | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Signal detection |
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| Signal assessment |
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| Enablement |
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Get certified for this role
Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
