Safety Database Specialist
Technical · Industry · PV IT Systems
Provides technical expertise on the computerised pharmacovigilance system, including database administration, configuration and validation.
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 database administration activities, providing technical expertise on PV systems, including planning and validation.
- Serve as a subject matter expert for PV systems and associated application integrations.
- Manage the computerised PV System.
- May conduct database build UAT and maintain quality-controlled database build documentation.
- Oversee the overall quality of the clinical database.
- Use data to help determine mishap causes and identify trends to prevent mishaps.
- Provide support in matters relating to operational and policy aspects of safety databases, including database configuration, data entry, data collection, dictionary values, application packages, event reporting procedures, and troubleshooting.
- Work closely with the division lead to ensure standardisation and accuracy of all data entered and retrieved from the safety databases.
Overall required level: Intermediate.The Safety Database Specialist is expected to hold expert technical knowledge of safety database administration and validation, with an intermediate understanding of the PV processes the system supports.
Prerequisites
Mandatory prerequisites
- →Degree or equivalent experience in information technology, life sciences or a related field
- →Experience administering a safety/PV database
Recommendations
- →Working proficiency in English
- →Knowledge of computer-system validation (CSV) practices
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 the PV system | Intermediate |
| ICSR data model and E2B(R3) structure | Expert |
| Data integrity principles (ALCOA+) | Expert |
Role-Specific Knowledge
| Topic | Level |
|---|---|
| Safety database administration and configuration | Expert |
| Computer-system validation and UAT | Expert |
| Dictionary management (MedDRA, WHODrug) and coding upversioning | Intermediate |
| System integrations, gateways and reporting rules | Intermediate |
| Change control and documentation practices | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| System administration |
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| Validation & quality |
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| Data stewardship |
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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.
