PV Data Scientist
Scientific · Industry · Data Management
Provides expert knowledge to analytical projects and drives advanced analytic algorithms and models.
Also known as: Process Data Scientist
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 expert knowledge to analytical projects, generate hypotheses and scoping in PV and drive the definition, design, implementation and validation of advanced analytic algorithms and models.
- Transform data science prototypes to validated end to end solutions as well as perform complex simulations, modelling and machine learning algorithms and integrate multi-layered data models.
- Analyse diverse internal and external sources for value-adding benefit/risk information concerning medical products by leveraging complex statistical and predictive models.
- Develop digital strategies to extract benefit/risk information from unstructured information, including literature, social media, and adverse events source documents.
- Ensure FAIR (Findable, Accessible, Interoperable and Re-usable) data principles before including data sources in the PV data ecosystem.
- Develop dashboards for real-time monitoring and trending of potential safety signals in external data sources.
- Design and implement novel methods for PV.
- 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 Data Scientist 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 |
|---|---|
| ICSR lifecycle: receipt, triage, data entry, quality controlRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Expert |
| ICH E2A / E2B(R3) data elements and expedited reportingRef: ICH E2A — Clinical Safety Data Management; ICH E2B(R3) — Electronic Transmission of ICSRs | Expert |
| MedDRA and WHODrug coding conventionsRef: MedDRA (MedDRA MSSO); WHODrug (Uppsala Monitoring Centre) | Intermediate |
| Data integrity principles (ALCOA+) | Intermediate |
| Signal management process (GVP Module IX)Ref: EMA GVP Module IX — Signal management (Rev 1) | 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 |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Basic |
| Training, education and capacity buildingRef: WHO Pharmacovigilance Core Curriculum for University Teaching | Basic |
| Benefit–risk assessment methodologyRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
| Biostatistics and quantitative safety analysis | Intermediate |
| Statistical, machine-learning and NLP methods for safety data | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Case management |
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| Coding |
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| Data quality |
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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.
