Medication Safety Officer
Scientific · Healthcare
Guides the design, implementation and evaluation of safe medication systems within a hospital.
Also known as: Drug Safety Officer, PV Clinical Officer
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
- Work with medical staff, pharmacy staff, nursing staff, and other pertinent health care providers.
- Responsible for guiding the design, implementation, maintenance, and evaluation of safe medication systems within a hospital.
- Work collaboratively with all members of the healthcare team, pharmacists, nursing staff, medical staff leadership, and patient safety.
- Assess medication use system processes, identify opportunities to improve medication use safety and review, design solutions for system failures, and institute practice changes.
- Serve as a subject matter expert for all medication safety initiatives and efforts, and work collaboratively to investigate, implement and monitor medication safety initiatives.
- Actively participate in outstanding customer service and accept responsibility in maintaining relationships that are equally respectful to all.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the Medication Safety Officer role. As a scientific role, intermediate-to-expert command of the relevant scientific domain and its regulatory context is 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 | Intermediate |
| The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Intermediate |
| Individual case safety report (ICSR) management and regulatory reporting timelinesRef: EMA GVP Module VI (Rev 2); ICH E2D(R1); ICH E2B(R3) | Intermediate |
Role-Specific Knowledge
Includes topics derived from this role's job description.
| Topic | Level |
|---|---|
| Medication error and adverse-drug-event management in healthcare settingsRef: EMA Good practice guide on recording, coding, reporting and assessment of medication errors (EMA/762563/2014, 2015) | Expert |
| Reporting of adverse drug reactions to national spontaneous-reporting systemsRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Expert |
| Safe medication-use systems and patient safetyRef: WHO Medication Without Harm — Global Patient Safety Challenge (WHO/HIS/SDS/2017.6, 2017) | Intermediate |
| Root-cause analysis and medication-safety improvement | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Medication safety |
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| Incident management |
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| Improvement & education |
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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.
