Local Responsible Person
Technical · Industry · PV Systems
Acts as the local person responsible for pharmacovigilance in a country.
Also known as: LSR – Local Safety Responsible, LPPV – Local Contact Person for PV
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
- Act as a single contact point for the NCA on a 24-hour basis, if applicable.
- Oversee the local PV system for collection and reporting of safety information to the concerned NCA.
- Monitor local literature for relevant safety information.
- Oversee PSMF, its content and maintenance, and ensure the availability of the PSMF to the NCA, if applicable.
- Aware of safety profiles and any emerging safety concerns in relation to the medicinal products for which the MAH holds authorizations.
- Inform about local requirements and needs for local access in regards to information about all suspected adverse events that have been reported to employees of the MAH.
- Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate.
- Collaborate with RA to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
- Collaboration with MA for the review and approval of safety aspects of local study protocols or PSP to ensure appropriate safety reporting to appropriate case management centres and RAs, as required.
- Provide technical and strategic input and participate in projects led by the regional PV team and international PV workstreams.
- Contribute, participate, and support team meetings, including materials preparation, meeting minutes writing, and action item tracking.
- 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 Local Responsible Person 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 |
| Audits and regulatory inspectionsRef: EMA GVP Module IV — Pharmacovigilance audits (Rev 1); GVP Module III — Pharmacovigilance inspections | Intermediate |
| ICSR lifecycle: receipt, triage, data entry, quality controlRef: EMA GVP Module VI — Collection, management and submission of reports (Rev 2) | Intermediate |
| Literature monitoring and reviewRef: EMA GVP Module VI (Rev 2) — literature monitoring | Basic |
| Budgeting, resourcing and business continuity | 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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