PSUR & DSUR Reporting Certification
Complete draft of Periodic Safety Update Reports (PSUR/DSUR) using automated line listings.
₹8,999
₹8,999
What's Included
- Standard Enrollment Access
- Digital Verified Certificate
- Community Peer Review
- Industry-Grade Simulation
- Expert-Level Simulation
- Elite Certification
- Complex Architecture
- Advisor Artifact Review
What is PSUR & DSUR Reporting Certification?
THE ACADEMY OUTPUT
THE ACADEMY OUTPUT
Your Deliverable: The PSUR/DSUR Reporting Portfolio Compile cumulative adverse event data across a simulated product safety history. Build line listings and summary tabulations. Draft a complete PSUR and DSUR section by section. Apply AI-assisted drafting tools and validate their output. Run quality checks. Handle a simulated regulatory query. Submit to regulatory standard with full documentation of methodology and data sources. > By the end of this program, you will have completed a real-world artifact that demonstrates your competency to potential employers — not a quiz score, not a participation certificate. Proof of execution.
Course Overview
Aggregate safety reporting is one of the most strategically important functions in pharmacovigilance — and one of the most technically demanding. Every pharmaceutical company with a marketed product must submit Periodic Safety Update Reports to regulatory authorities on a defined schedule, providing a comprehensive cumulative analysis of the drug's benefit-risk profile based on all available safety data. Development Safety Update Reports are required annually for all drugs in clinical development. Missing these submissions, or submitting reports that fail regulatory quality standards, triggers inspection findings, licence conditions, and in serious cases, market withdrawal proceedings. The professionals who build these reports carry significant regulatory responsibility.
This program builds the complete PSUR and DSUR competency stack from the ground up. You begin with the regulatory and documentation foundations — global regulatory bodies, GVP requirements, adverse event classification, and MedDRA coding — before moving into the ICSR-level data that feeds aggregate reports. From there you progress into the aggregate reporting workflow itself: PSUR architecture and ICH E2C(R2) requirements, DSUR structure and clinical development timelines, data aggregation methodology, line listing and summary tabulation construction, AI-assisted drafting workflows, benefit-risk evaluation frameworks, quality review processes, and regulatory submission procedures. MedDRA is trained as an integrated competency — coding accuracy, version management, and error resolution are embedded throughout because aggregate report integrity depends entirely on the quality of the underlying case coding.
By the end you carry a complete PSUR and DSUR reporting portfolio — compiled data, line listings, drafted report sections, quality documentation, and regulatory submission records — advisor-reviewed and published to your professional profile. In a function where documented execution capability is rare and consistently in demand, that portfolio is a direct hiring advantage.
Why This Over Everything Else
PSUR and DSUR reporting is taught in most pharmacovigilance training programs as a theory module — here is what a PSUR is, here is the ICH E2C(R2) structure, here are the regulatory timelines. None of that prepares you to sit down with a cumulative safety dataset, aggregate it correctly, build the line listings, draft the benefit-risk section, and submit a report that passes regulatory scrutiny. This program makes you do exactly that — inside a simulation that mirrors the real aggregate reporting environment, with AI tools integrated the way modern PV operations actually use them. You leave with a drafted report and a portfolio, not a definition.
What You'll Actually Learn
Curated Industry Competencies
- Global PV Regulatory Bodies — FDA, EMA, PMDA, CDSCO and their aggregate reporting mandates
- Adverse Event, SAE, and ADR Classification — regulatory definitions underpinning aggregate data
- Good Pharmacovigilance Practices — GVP Module VII: Periodic Safety Update Report requirements
- Introduction to MedDRA — dictionary structure and aggregate reporting application
- Pharmacovigilance Documentation Essentials — data standards and audit trail requirements for aggregate reports
- ICSR Overview and Structure — case-level data feeding aggregate safety analysis
- Source Document Review — clinical data extraction and verification for aggregate datasets
- Adverse Event Causality Assessment — evaluating causality across case series for aggregate analysis
- MedDRA Coding for ICSRs — coding accuracy as the foundation of aggregate report integrity
- ICSR Quality Checks — case-level data quality as a prerequisite for aggregate reporting
- PSUR Overview and Requirements — ICH E2C(R2) structure, content, and regulatory mandates
- DSUR Basics and Timelines — ICH E2F requirements, annual reporting obligations, and clinical development context
- Data Aggregation for Safety Reports — methodology for compiling cumulative adverse event datasets
- AI-Assisted PSUR Drafting — machine learning tools for section generation, data summarisation, and quality validation
- Line Listings and Summary Tabulations — construction, formatting, and regulatory standards
- PSUR Quality Checks — ICH E2C(R2) completeness criteria and regulatory submission readiness
- DSUR Case Study Analysis — applying aggregate analysis methodology to clinical development safety data
- Regulatory Submission of Aggregate Reports — submission procedures for FDA, EMA, and global agencies
- Handling PSUR and DSUR Queries — responding to regulatory authority requests for clarification or additional data
- MedDRA Hierarchy Architecture — five-level coding structure and aggregate reporting implications
- LLT, PT, and SOC Coding — accurate term selection as aggregate data foundation
- Coding Accuracy and Quality Controls — error identification and correction within aggregate datasets
- Coding Error Resolution — correcting MedDRA discrepancies before aggregate data lock
- MedDRA Version Updates — managing dictionary transitions across multi-year safety reporting periods
Systems You'll Use
Enterprise Software & Digital Workflows
Training includes hands-on work with the same tools, data standards, and regulatory frameworks used in real aggregate safety reporting operations globally.
- PSUR and DSUR drafting templates aligned to ICH E2C(R2) and E2F standards
- Cumulative adverse event dataset compilation and aggregation tools
- Line listing and summary tabulation construction environments
- MedDRA terminology browser — hierarchy navigation and coding verification for aggregate datasets
- AI-assisted PSUR drafting and section generation tools
- NLP-based data summarisation and benefit-risk evaluation support systems
- Oracle Argus Safety — cumulative data extraction and aggregate reporting workflow integration
- E2B(R3) case data reconciliation for aggregate dataset completeness
- WHO VigiBase and FDA FAERS reference interfaces for cumulative signal context
- Regulatory submission portals and electronic filing frameworks for FDA and EMA
- PSUR and DSUR quality review checklists and sign-off documentation systems
- Regulatory query management and response documentation workflows
Career Outcomes
Professional Roles & Impact
- Aggregate Reporting Specialist
- PSUR/DSUR Writer
- Pharmacovigilance Medical Writer
- Regulatory Safety Scientist
- Periodic Reporting Associate
- Drug Safety Scientist
- Benefit-Risk Assessment Specialist
- PV Regulatory Affairs Associate
- Clinical Safety Analyst
- Global Safety Reporting Coordinator
Average starting salary (India): ₹5–11 LPA
Global range: $55K–$95K USD
Aggregate safety reporting sits at the senior end of the pharmacovigilance function — above case processing, requiring both technical data competency and the regulatory judgement to evaluate a product's cumulative benefit-risk profile. Professionals with documented PSUR and DSUR drafting experience are among the most consistently sought-after specialists in the drug safety job market, particularly at pharmaceutical companies managing large marketed portfolios and CROs contracted to manage aggregate reporting obligations for global clients. AI-assisted reporting proficiency is an increasingly specified requirement at the top employers in this space.
Who This Program Is For
Eligibility & Background
- Pharm.D
- Pharm.D (PB)
- B.Pharm
- M.Pharm
- MBBS
- MD
- BDS
- MDS
- BHMS
- BAMS
- BUMS
- BSMS
- B.Sc Nursing
- M.Sc Nursing
- B.Sc Life Sciences
- B.Sc Biomedical Sciences
- B.Sc Biotechnology
- M.Sc Biotechnology
- PG Diploma in Pharmacovigilance
- PhD Pharmacology
Enrollment & Format
Format: Self-paced sprint with structured case milestones. Start: Within 24 hours of enrollment — rolling access. Completion: 7–9 days recommended. Access does not expire.
What Happens After You Enroll
Instant access to the ΩMEGA simulation environment and aggregate reporting workbench
Onboarding brief + first cumulative safety dataset assigned within 24 hours
Work through PSUR and DSUR drafting scenarios of escalating regulatory complexity
Submit your complete PSUR/DSUR Reporting Portfolio for Advisor review
Receive your verified digital credential upon sign-off
Portfolio artifact published automatically via AURIX
LinkedIn-ready certificate with one-click integration
LEARNING PATHWAY
FAQS
Is this Pharmacovigilance certification valid for global roles?
Are PSUR and DSUR reports generated using automated line listings?
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