The Professional Micro-Credential in Pharmacovigilance is an applied, knowledge- and skills-based programme for health-profession graduates and eligible pharmacy students. Its four-module curriculum follows the medicine lifecycle from preclinical development, clinical phases, GLP/GCP/GMP, bioequivalence and eCTD registration through post-authorization pharmacovigilance. Learners address PV guidelines and systems, ICSR and literature workflows, medication errors and misuse, causality and signals, PSMF and SOPs, safety agreements, total quality management, ISO 9001, audits, inspections, RMPs, PSURs, Phase IV studies, additional monitoring, risk minimization, SmPC/PIL communication, pharmacoepidemiology, statistics, MedDRA, biologics and biosimilars, antimicrobial resistance, veterinary and device vigilance, manufacturing and supply-chain defects, computerized PV databases, rational drug use, industry/hospital/pharmacy practice, and PV service development. The course schedules 109 teaching hours plus 16 hours of assignments and knowledge assessments, producing a total workload of 125 hours (5 ECTS). Achievement is determined solely through rubric-based assessment of the specified knowledge and skills, using evidence from scheduled knowledge checks, assignments, work groups, and practical case activities. The credential has no capstone, portfolio, presentation, or oral defense, and attendance alone is insufficient.

• good laboratory practice (ESCO)
• pharmaceutical products (ESCO)
• pharmaceutical legislation (ESCO)
• pharmaceutical technology (ESCO)
• pharmaceutical manufacturing quality systems (ESCO)
• pharmacotherapy (ESCO)
• pharmacovigilance legislation (ESCO)

• ensure products meet regulatory requirements (ESCO)
• implement quality management systems (ESCO)
• manage clinical risk (ESCO)
• manage medication safety issues (ESCO)
• ensure pharmacovigilance (ESCO)
• maintain pharmaceutical records (ESCO)
• contribute to registration of pharmaceutical products (ESCO)
• develop pharmaceutical drugs (ESCO)
• ensure quality assurance for pharmaceutical products (ESCO)
• test medicinal products (ESCO)

Pharmacists, PharmD graduates, physicians, bachelor-level nursing graduates, and eligible Pharmacy/PharmD students after pharmacology coursework.

Evidence of eligible qualification/status; prerequisite pharmacology for current students; basic technical English reading and digital skills. 

125 Hours

Introduction to the programme; drug life cycle

Preclinical drug development; Good Laboratory Practice (GLP)

Pre-authorization clinical studies: Phases I, II and III

Good Manufacturing Practice overview

Bioequivalence; QA/QC; stability; scale-up and post-approval

Drug registration guidelines and electronic CTD (eCTD)

Pharmacovigilance guidelines

PV lifecycle; ICSR requirements; literature review

Case-studies practical

Collection of medication errors, misuse, abuse and related reports

Causality assessment and signal management

Practical causality assessment and signal detection

Pharmacovigilance quality system

PSMF and writing standard operating procedures

Safety agreement and work group

Total Quality Management and tools

ISO 9001:2015

Planning, preparing and conducting an audit for the PSMF

Regulatory-inspection preparation; auditor, observer and inspector roles

Risk management plan

Periodic Safety Update Report

Practical RMP and PSUR

Phase IV studies connected to pharmacovigilance

Additional monitoring and risk-minimization measures; practical examples

Summary of Product Characteristics and Patient Information Leaflet

Pharmacoepidemiology and pharmacovigilance

PV for biological products and biosimilars

Minimum PV-system requirements; high-alert-medication work groups

Pharmacovigilance and antimicrobial resistance

Statistical analysis in PV; introduction to MedDRA

Pharmacovigilance in veterinary medicine

Pharmacovigilance in medical devices

Manufacturing defects; supply-chain risk assessment

Drug promotion and practical work groups

Computerized PV workflow and databases

PV communication; practical cases and work group

Industry perspectives; PV in hospitals and pharmacies

Rational drug use

Business development, job opportunities and PV service providers

Pre-course diagnostic rubric

Five interim/module knowledge assessments

Three assignments/work groups

ICSR and practical case activities

Final knowledge assessment

Matched post-course rubric

Credential decision

Assessment model

• food regulatory advisor (ESCO)
• legal policy officer (ESCO)
• pharmaceutical quality specialist (ESCO)
• pharmaceutical goods distribution manager (ESCO)
• pharmacy lecturer (ESCO)
• medical goods specialized seller (ESCO)

The Micro-credential presents four modules under a proposed professional diploma with stackable microcredentials. For this single registration file, the complete four-module programme is treated as one proposed 5-ECTS micro-credential. It does not automatically confer academic credit or professional licensure.