Safety Database Specialist
Technical · Regulatory Authority · PV IT Systems
Provides technical expertise on the regulatory authority's safety database.
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, for 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 computerized PV System.
- May conduct database build UAT and maintain quality-controlled database build documentation.
- Oversee the overall quality of the 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.
- 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.
- Contribute, participate, and support team meetings, including materials preparation, meeting minutes writing, and action item tracking.
Overall required level: Intermediate.Draft competency standard for the Safety Database Specialist role. As a technical role, expert-level command of the specific systems, tools and processes is expected, with working knowledge of the surrounding regulations. Levels are an initial proposal derived from the role's job description and typical pharmacovigilance practice, pending expert review.
Prerequisites
Mandatory prerequisites
- →Relevant qualification or demonstrable experience in the role's domain
- →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 | Basic |
| 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 |
|---|---|
| Safety database administration and configurationRef: ICH E2B(R3); EMA EudraVigilance | Expert |
| Computer-system validation (CSV) and UATRef: EU GMP Annex 11 — Computerised systems | Expert |
| PSMF and Safety Data Exchange Agreements (SDEA)Ref: EMA GVP Module II — Pharmacovigilance system master file (Rev 2) | Intermediate |
| System integrations, gateways and reporting rulesRef: ICH E2B(R3) — Electronic Transmission of ICSRs | Intermediate |
| PV policy, legislation and guideline developmentRef: Regulation (EC) No 726/2004; Directive 2001/83/EC | 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 |
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| Governance |
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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.
