What each pharmacovigilance role must know and do
Each standard is divided into three categories — theoretical knowledge, practical skills, and attitude — and specifies the required level for each topic on a four-level scale: Non-applicable, Basic, Intermediate and Expert. Standards are developed jointly by the ISoP Special Interest Group on PV Professional Qualification Framework and the Institute of Pharmacovigilance.
Published standards
Finalised competency standards available for certification.
Pharmacovigilance Awareness for Healthcare Professionals
Foundational pharmacovigilance awareness for doctors, nurses, pharmacists and other healthcare professionals.
Global/HQ QPPV
Implements global PV services and oversees the functioning of PV systems in all relevant aspects.
Draft standards for review
Working drafts prepared for expert review. These are not yet official GPPC standards and are clearly labelled as drafts on each role page.
Head of Safety
Accountable leader for the establishment and maintenance of pharmacovigilance governance across the organisation.
EU QPPV
Qualified Person Responsible for Pharmacovigilance residing and operating in the EU/EEA, the single PV contact point for the EMA and member-state authorities.
Head of PV Operations
Provides guidance and direction to ensure pharmacovigilance compliance at regional and country level.
Medical Reviewer
Provides medical oversight of individual case safety reports — seriousness, expectedness, causality, coding and narratives.
Signal Evaluator
Drives signal detection and evaluation activities and educates stakeholders on signal management methodologies and tools.
Safety Database Specialist
Provides technical expertise on the computerised pharmacovigilance system, including database administration, configuration and validation.
UK QPPV
Establishes and maintains the UK PV system and acts as the single PV contact point for the MHRA.
PV Policy Lead
Coordinates the exchange of policy-related information and ensures resources are available to implement relevant policies.
Head of PV
Leads the pharmacovigilance function within a regulatory authority.
PV Policy Lead
Coordinates and disseminates PV policy across teams within a regulatory authority.
Head of PV Academic Program
Responsible for the overall development and coordination of a specific PV academic program.
Head of Quality Assurance PV
Enhances the quality culture and is in charge of internal and external audits.
Head of Medical PV
Manages and supports medical and safety oversight and directs the Safety Management Team.
Head of PV Data Science
Defines and develops overall analytics solutions and data-services vision for PV.
Head of PV Pharmacoepidemiology
Serves as the strategic lead for epidemiologic support of approved and developmental drugs.
PV Project Manager
Oversees and coordinates work and collaboration on PV projects.
PV Vendor Manager
Determines and oversees outsourced PV tasks and manages service-provider relationships.
Head of Signal Management
Leads identification and validation of new safety signals and trends within a regulatory authority.
Head of PV Medical Assessment
Leads the PV medical-assessment department and contributes to organisational strategy.
Head of Data Management
Formulates strategies to improve regional data-management efficiencies.
Head of Risk Management
Provides strategic guidance on risk-management planning documents and activities.
Head of PV Inspectorate
Leads the PV inspectorate, ensuring appropriate objectives, analytics and targets.
Team Leader in PV
Provides leadership, oversight and direction for PV projects within a regulatory authority.
PV Academic Program Manager
Oversees the development of a detailed PV academic program.
PV Academic Project Manager
Oversees and coordinates work and collaboration on PV academic projects.
PV Data Supervisor
Ensures data-entry services are accurate, efficient and timely and oversees the daily workflow.
PV Data Scientist
Provides expert knowledge to analytical projects and drives advanced analytic algorithms and models.
Medical Evaluator
Leads medical review of aggregated safety reports and prepares benefit/risk sections.
Risk Management Scientist
Performs safety analyses and contributes to development and maintenance of RMPs/REMS.
Quality Assurance Scientist
Supports audit activities, the CAPA process and continuous improvement of the QMS.
PV Systems Architect
Designs strategic goals and tactical plans for managing and maintaining PV systems and software.
PV Medical Writer
Authors PV documents including PBRERs, RMPs, REMS and DSURs.
PBRER Writer
Specialises in authoring Periodic Benefit-Risk Evaluation Reports.
RMP Writer
Specialises in authoring Risk Management Plans.
REMS Writer
Specialises in authoring Risk Evaluation and Mitigation Strategies.
DSUR Writer
Specialises in authoring Development Safety Update Reports.
PV Pharmacoepidemiologist
Conducts pharmacoepidemiologic studies and reviews to support drug safety.
PV Biostatistician
Provides statistical expertise for PV studies and safety analyses.
PV Medical Assessor
Performs medical assessment of safety data within a regulatory authority.
PV Scientific Assessor
Performs scientific assessment of PV data within a regulatory authority.
PV Inspector
Conducts pharmacovigilance inspections on behalf of a regulatory authority.
Senior Researcher
Leads pharmacovigilance research within an academic setting.
PV Scientist
Conducts pharmacovigilance science within an academic setting.
PV Data Scientist
Applies data science to pharmacovigilance research in academia.
PV Pharmacoepidemiologist
Conducts pharmacoepidemiologic research in academia.
PV Lecturer
Teaches and instructs university students in the theory and practice of pharmacovigilance.
Medication Safety Officer
Guides the design, implementation and evaluation of safe medication systems within a hospital.
IT PV Systems Supervisor
Leads compilation of the SDLC and the creation, validation and configuration of PV systems.
Data Entry Specialist
Responsible for case receipt/book-in processes, including duplicate checks and case booking.
Terminology Coder
Codes adverse-event terms and medical history using controlled terminologies.
Product Coder
Codes medicinal products using controlled product dictionaries.
Data Entry Supervisor
Supervises the data-entry team and workflow.
Signal Management Administrator
Provides administrative support to signal-management activities.
Risk Management Administrator
Provides administrative support to risk-management activities.
PV Quality Assurance Administrator
Provides administrative support to PV quality-assurance activities.
PV Auditor
Plans and conducts pharmacovigilance audits.
PSMF Administrator
Maintains the Pharmacovigilance System Master File.
SDEA Administrator
Maintains Safety Data Exchange Agreements.
Local Responsible Person
Acts as the local person responsible for pharmacovigilance in a country.
PV Studies Administrator
Provides administrative support to PV studies and data-collection schemes.
Safety Database Specialist
Provides technical expertise on the regulatory authority's safety database.
IT PV Systems Supervisor
Leads PV system development and validation within a regulatory authority.
Data Entry Specialist
Responsible for case receipt and book-in within a regulatory authority.
Terminology Coder
Codes terms using controlled terminologies within a regulatory authority.
Product Coder
Codes products using controlled dictionaries within a regulatory authority.
Data Entry Supervisor
Supervises the regulatory authority's data-entry team.
Signal Management Administrator
Provides administrative support to signal management within a regulatory authority.
Risk Management Administrator
Provides administrative support to risk management within a regulatory authority.
PSMF Assessor
Assesses Pharmacovigilance System Master Files on behalf of a regulatory authority.
PV Inspector
Conducts pharmacovigilance inspections on behalf of a regulatory authority.
Data Quality Reviewer
Reviews the quality of PV data within a regulatory authority.
PV Research Administrator
Provides administrative support to pharmacovigilance research.
PV Assistant Lecturer
Supports teaching of pharmacovigilance in an academic setting.
Every role in the framework has a draft standard
Draft competency standards are published for all roles in the framework and are being reviewed and refined by subject-matter experts. Browse them by role in the Career Framework.
Browse all roles →
