PBRER Writer
Scientific · Industry · PV Medical Writing
Specialises in authoring Periodic Benefit-Risk Evaluation Reports.
Also known as: PSUR Writer
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
- Plan and organize workload for assigned projects and tasks, i.e., identify project needs, track timelines, and implement requests.
- Prepare PBRER and addenda to the safety/regulatory documents following relevant SOPs and templates.
- Perform QC of PBRER and addenda to the safety/regulatory associated documents in accordance with relevant SOPs and QC checklists.
- Function as the medical writing lead on a variety of projects.
- Participate in inspection/audit related readiness activities and provide support for internal and external PV audits.
- Train, support and work closely with other staff and the company’s divisions to develop appropriate project plans.
Overall required level: Intermediate.Draft competency standard for the PBRER Writer 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 |
|---|---|
| Aggregate safety reports (PBRER/PSUR, DSUR)Ref: EMA GVP Module VII (PSUR); ICH E2C(R2) (PBRER); ICH E2F (DSUR) | Expert |
| Risk management plan (RMP) / REMS authoringRef: EMA GVP Module V — Risk management systems (Rev 2) | Intermediate |
| Regulatory templates, SOPs and QC checklistsRef: EMA GVP Module I — Pharmacovigilance systems and their quality systems | Expert |
| Benefit–risk narrative and safety data interpretationRef: ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER) | Intermediate |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Authoring |
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| Quality control |
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| Project delivery |
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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.
