Introduction to Pharmacovigilance
Introduction to Pharmacovigilance
Version 3.0
Last update on 21/10/2025
Learn pharmacovigilance online. Build practical skills in drug safety, reporting, and compliance with EMA, FDA, ICH, and WHO frameworks. Start your certification today.
Version 3.0
Last update on 21/10/2025
4.33
(58 Reviews)
Introduction to Pharmacovigilance
Last update on 21/10/2025
- beginner
- + Certificate
- Available on app
- Online at your own pace
- Shareable certificate of completion
About the Introduction to Pharmacovigilance
Master the fundamentals of pharmacovigilance with this comprehensive online course in drug safety and compliance. Designed for pharmaceutical, regulatory, and quality professionals, this training explains how medicines are monitored for safety under EMA, FDA, ICH, and WHO frameworks.
You’ll explore how safety information becomes validated data, how adverse events are reported, and how Regulatory Affairs and Quality Assurance collaborate to maintain compliance.
The course includes interactive skill-check exercises, real-world case studies, and downloadable resources to support applied learning. Upon completion, you’ll earn a certificate in Pharmacovigilance, marking progress toward the Pharmuni Pharmacovigilance Specialist Career Path. Gain the knowledge to ensure patient protection, strengthen regulatory trust, and advance your career in global drug safety.
ISO 9001
Quality Management System
Certificate Registration No.: 12 100 60610 TMSPharmuni Certificate
Zamann Pharma Support GmbH
Personnel qualification in the field of pharmacy, medical technology and quality assurance.
Consulting service in the field of pharmacy, medical technology and quality assurance.
Your Learning Objectives
This foundational course introduces the principles and practices that underpin PV systems worldwide. You will explore how regulatory authorities such as the EMA, FDA, ICH, and WHO shape global PV expectations, and how each company must integrate these requirements into its Quality Management System (QMS).
Learning Objective 1
Explain the purpose and scope of Pharmacovigilance (PV) in maintaining patient safety and regulatory compliance under EMA, FDA, and ICH frameworks.
Learning Objective 2
Classify safety information by distinguishing between Adverse Events (AEs), Adverse Drug Reactions (ADRs), and Product Quality Complaints.
Learning Objective 3
Identify primary pharmacovigilance data sources including EudraVigilance, spontaneous reports, and medical literature, and describe how each contributes to safety monitoring.
Learning Objective 4
Describe how pharmacovigilance activities fit within the broader pharmaceutical quality system and contribute to regulatory inspection readiness.
Learning Objective 5
Outline the core responsibilities and structure of a Pharmacovigilance Department and its collaboration with Regulatory Affairs, Quality Assurance, and Medical Information functions.
Learning Objective 6
Demonstrate correct adverse-event reporting principles, including timelines, documentation requirements, and data-protection obligations.
Learning Objective 7
Evaluate professional behaviours that support a culture of pharmacovigilance compliance, including ethical communication and prompt reporting of safety information.
This course is included in these career paths
Discover tailored career paths designed to help you grow in the pharmaceutical industry. Whether you're just starting out or looking to specialize, find the roles, skills, and learning steps that align with your goals.
Benefits of this Course
Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.
- Downloadable Resources
- Fast-Tracked Qualification
- Exclusive Assessment Quiz
- Skill Tree Levelup
- Customer Support
- Sharable & Downloadable Certification
FAQs
How do I enroll in the Introduction to Pharmacovigilance online course?
Create a free Pharmuni account from our registration page, open this course page and click “Start Learning” button on top of the page. You can start learning instantly from any device.
How do I complete the quiz and download my certificate?
Work through all lessons, then pass the short quiz with ≥ 80 %. When you pass, the Receive Certificate button appears on top of this page—click it to download your PDF certificate, and you’ll also find it later under My Certificates in your dashboard.
Is the Introduction to Pharmacovigilance certificate recognized, and how long is it valid?
Pharmuni certificates are backed by ISO 9001 of our mother company, Zamann Pharma Support, and are accepted by employers worldwide. Each certificate stays valid for two years from its issue date. You can learn more about our certificates here.
What career benefits will I gain from Introduction to Pharmacovigilance?
To create this course, we constantly monitor the job market. The course teaches job-ready skills, boosting your credibility for pharmaceutical roles, especially in Quality Management. Add the credential to LinkedIn or your CV to stand out in recruiter searches.
How long does Introduction to Pharmacovigilance take, and can I learn at my own pace?
All Pharmuni content is fully self-paced—study whenever it suits you. Most learners finish a module within one week, but there is no deadline as long as your subscription is active.
What if I don’t pass the quiz the first time?
No worries—you can retake the quiz (and the course) as many times as you need until you achieve the passing score and download your certificate.
How do I upgrade to Pharmuni Premium, and what extra perks do I get?
Log in, visit the Plans page and choose a Monthly or Annual plan in your local currency. Premium unlocks 45+ courses, ISO-9001 backed certificates, unlimited Skill-Tree access, a pharma CV & cover-letter builder, and a free 30-minute VIP career-coaching session every month.