Head of Signal Management
Managerial · Regulatory Authority · Signal Management
Leads identification and validation of new safety signals and trends within a regulatory authority.
Also known as: Head of Signal Detection, Signal Management Lead
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
- Identify and validate new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
- Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance.
- Provide recommendations for further signal evaluation.
- Participate as a member of the matrix teams to address product-specific safety issues, assist in the development of signal evaluation strategies, and participate in signal evaluation.
- Communicate findings from routine and ad hoc signal detection and assessment activities.
- Assist in the development and implementation of surveillance of adverse event reports for potential safety and product quality issues.
- Assist in the evaluation of novel, computer-assisted tools, and methodologies for the analysis of safety data, including piloting new data sources and methodologies.
- Contribute to transparency and communication initiatives through the provision of scientifically rigorous and consistent information to promote the safe and effective use of medicines.
- Liaise with and provide technical information, advice, and guidance on relevant PV matters to other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public.
- Support external compliance monitoring with PV obligations.
- Participate at all levels (internally and externally) in the formulation and preparation of regulatory policies, guidelines, legislation, and opinions.
- Propose process improvements.
- Provide adequate support, motivation, encouragement, and effective management for all relevant staff.
- Develop and implement relevant training.
Overall required level: Expert.Draft competency standard for the Head of Signal Management role. As a managerial role, expert-level knowledge of the managed function and strong oversight, compliance and people-management competencies are expected. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →University degree in medicine, pharmacy, life sciences or a related discipline
- →Relevant pharmacovigilance experience appropriate to the role
Recommendations
- →Working proficiency in English
- →Familiarity with the applicable GVP modules
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 Good Pharmacovigilance Practices (GVP) overviewRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems; EU Reg (EC) 726/2004 & Dir 2001/83/EC | Expert |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Expert |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Expert |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | Expert |
| Signal detection methodologies and disproportionality analysisRef: EMA GVP Module IX Addendum I (methodological aspects of signal detection); CIOMS Working Group VIII | Expert |
| Signal validation, assessment and prioritisationRef: EMA GVP Module IX — Signal management (Rev 1) | Intermediate |
| Aggregate safety data sources and their limitationsRef: CIOMS Working Group VIII — Practical Aspects of Signal Detection in Pharmacovigilance (2010) | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Intermediate |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | Expert |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Detection |
|
|
|
| Assessment |
|
|
|
| Reporting |
|
|
|
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.
