PV Biostatistician
Scientific · Industry · Data Collection Schemes
Provides statistical expertise for PV studies and safety analyses.
Also known as: Biostatistician
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
- Provide oversight of statistical aspects in the design and analysis of studies, including project management, statistical analysis, report preparation, and advising other project statisticians.
- Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contribute to writing appropriate protocol sections.
- Write/review analysis plans and guide others on the team in its implementation.
- Define appropriate methods and procedures for statistical analysis.
- Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming.
- Provide statistical advice and sample size planning. Help with the development and implementation of statistical analysis plans.
- Carry out complex statistical analyses and work with statistical software.
- Prepare and present study results.
- Coordinate with programs and data management personnel as to database maintenance, updating, and documentation.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Develop and deliver relevant training.
Overall required level: Intermediate.Draft competency standard for the PV Biostatistician 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 |
|---|---|
| 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 |
| Safety database administration and configurationRef: ICH E2B(R3); EMA EudraVigilance | Intermediate |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| Biostatistics and quantitative safety analysis | 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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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.
