Aggregate Report Writing in Pharmacovigilance
Aggregate Report Writing in Pharmacovigilance
Version 1.0
Released on 08/09/2025
An advanced course on creating inspection-ready aggregate reports (PSUR, PBRER, DSUR) that meet EMA, FDA, and PMDA requirements through robust planning, quality control, and regulatory response strategies.
- English
- Available on app
- + Certificate
Version 1.0
Released on 08/09/2025
5
(1 Reviews)
Aggregate Report Writing in Pharmacovigilance
Released on 08/09/2025
- advanced
- + Certificate
- Available on app
- Online at your own pace
- Shareable certificate of completion
About the Aggregate Report Writing in Pharmacovigilance
Master the skills needed to plan, write, and quality-check aggregate safety reports that meet global regulatory requirements. This course provides step-by-step guidance on preparing PSURs, PBRERs, and DSURs, with practical tools for managing data cut-off dates, database locks, and multi-region submissions. Learn how to align with EMA, FDA, and PMDA expectations, coordinate effectively with cross-functional teams, and apply robust quality control techniques to produce inspection-ready reports. You will also explore how to respond to regulatory authority feedback, revise benefit–risk analyses, and integrate lessons learned to improve future reporting cycles. This course combines regulatory knowledge with applied strategies, ensuring you can deliver consistent, compliant, and globally harmonised submissions that withstand inspection and build regulator confidence.
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
Through a combination of case studies, skills checks, videos, and visual explanations, this course will guide you step by step toward building the competencies needed for effective aggregate report writing. By the end of this course, learners will be able to:
Learning Objective 1
Differentiate between PSUR, PBRER, and DSUR by comparing their structure, content, and regulatory purpose under EMA, FDA, and ICH guidelines.
Learning Objective 2
Evaluate pharmacovigilance safety data to perform a balanced benefit–risk assessment that meets international regulatory expectations.
Learning Objective 3
Design submission timelines and schedules for EMA, FDA, and PMDA aggregate report requirements, aligning with global regulatory review processes.
Learning Objective 4
Coordinate cross-functional stakeholders (RA, QA, Clinical, PV, Medical Writing) to collect and compile data for pharmacovigilance and regulatory reports.
Learning Objective 5
Apply quality control measures to prevent common errors and compliance issues in aggregate reporting and periodic safety submissions.
Learning Objective 6
Integrate signal detection outcomes into PSURs, PBRERs, and DSURs to create inspection-ready periodic reports.
Learning Objective 7
Revise aggregate reporting strategies in response to EMA/FDA regulatory authority feedback to maintain compliance and improve future submissions.
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 Aggregate Report Writing in 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 Aggregate Report Writing in 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 Aggregate Report Writing in 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 Aggregate Report Writing in 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.