PV Studies Administrator
Technical · Industry · Data Collection Schemes
Provides administrative support to PV studies and data-collection schemes.
Also known as: PV 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
- Set up, design, and maintain the study files.
- Develop, review, and edit studies related documentation including but not limited to Case Report Forms, Informed Consent Forms, study-specific handbooks, guidelines, and checklists.
- Oblige to notify the start and end of the safety study to regulatory authorities.
- Responsible for submission of a study protocol, submission of a final report as soon as possible within 12 months of the end of the data collection.
- Monitor studies to ensure absolute adherence to GVPs.
- Assist with study protocol design, development and/or review, if required.
- Complete and compile all necessary study documentation and information to gain appropriate regulatory and ethics committees’ approval, where required.
- Perform pre-study initiation, interim monitoring, and closeout visits as required.
- Liaise with the Principal Investigator, clinical operations staff and Sponsor representatives as required.
- Organise/attend investigator meetings as required.
- Prepare monitoring status reports for the Sponsor.
- Archive study documentation and correspondence.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
Overall required level: Intermediate.Draft competency standard for the PV Studies Administrator 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 |
|---|---|
| Pharmacoepidemiology study design (PASS/PAES)Ref: EMA GVP Module VIII (Rev 3); ENCePP Guide on Methodological Standards | Expert |
| Real-world evidence (RWE) and data sourcesRef: ENCePP Guide on Methodological Standards in Pharmacoepidemiology | Intermediate |
| Biostatistics and study analysis | Intermediate |
| GVP Module VIII (post-authorisation safety studies)Ref: EMA GVP Module VIII — Post-authorisation safety studies (Rev 3) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | 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 |
|---|---|---|---|
| Study design |
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| Analysis |
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| Evidence |
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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.
