The rapid integration of AI across PV and MI is transforming how data is collected, processed and communicated. AI literacy is emerging as a core professional capability, to navigate the opportunities and risks that AI introduces.
The PIPA AI workstream, which includes industry professionals with experience of AI in both MI and PV, have developed an AI Competency Framework. This framework provides a unified structure to help organisations assess current competency, design learning pathways and overcome employee hesitancy, to embed responsible AI practice into professional development and foster a culture of innovation.
The framework provides a structured, five-level AI literacy competency ladder designed to:
- Help PV and MI leaders identify the level of AI proficiency required for each role.
- Guide learning and development teams in planning progressive upskilling.
- Promote a culture of ethical, transparent, and confident use of AI in regulated environments.
This guidance is intended for pharmaceutical and biotechnology organisations seeking to define and develop AI competencies within MI and PV.
Read: Competency Framework for Artificial Intelligence in Medical Information and Pharmacovigilance
PIPA: who we are and why join us
Although developed for the benefit of PIPA members, PIPA has decided to make this document freely available to anyone outside of the association.
This document is just one of a wide range of guidance documents developed, and peer-reviewed, by experienced industry professionals on behalf of PIPA to assist companies with providing compliant and ethical MI and PV services.
PIPA membership is available for just £110 per year and is open to individuals based both in the UK and overseas.
Join now: https://pipaonline.org/register/
The benefits of PIPA membership include:
- Guidance – we provide professional guidance and resources for medical information and pharmacovigilance – further details below.
- Training – we offer quality face-to-face (usually delivered via Teams) and online training courses developed by industry professionals for industry professionals.
- Access to PIPA’s monthly journal, PIPELINE – and its full back catalogue, containing topical articles written by industry experts, regulators and healthcare professionals.
- Discussion Forums – our online discussion forums allow members to anonymously pose questions about MI, PV and related topics to the PIPA Committee and wider PIPA membership for their input.
- Webinars – we host monthly webinars that are free to members.
- Conference and networking – we run an annual conference to give members the opportunity to learn, network and exchange ideas.
Current guidance documents available include:
Medical Information
Guidance documents
- UK Guidelines for the Pharmaceutical Industry Medical Information Departments
- PIPA Guidance: Responding to Patient Enquiries
Supplementary resources
- MI Business Continuity Plan Template
- MI Reference Guideline Template
- MI Audit and Inspection Readiness Checklist
- MI SOP and WI Templates
- MI Customer Satisfaction Questionnaire Template
- MI Manager’s Checklist
- MI Competency Areas Checklist
Pharmacovigilance
Guidance documents
- UK Guidelines on Standards for Pharmacovigilance Departments – Post-Marketing
- UK Guidelines on Standards for Pharmacovigilance Departments – Clinical Pharmacovigilance
- Guidelines for Signal Management
- UK Guidelines for the Pharmaceutical Industry Qualified Person for Pharmacovigilance (QPPV)
- Guidelines for Pharmacovigilance System Master File (PSMF)
- UK Medical Device Vigilance Guidelines
- EU Medical Device Vigilance Guidelines
- Guidance Notes on UK Data Protection in Post-Marketing Pharmacovigilance
