Online Diploma in Pharmacovigilance & Drug Safety - Univista EdTech
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Course Overview
The Online Diploma in Pharmacovigilance & Drug Safety by Univista EdTech is a comprehensive program designed to develop skilled professionals capable of monitoring, evaluating, and ensuring the safety of pharmaceutical products throughout their lifecycle.
This program provides in-depth knowledge of adverse event reporting, signal detection, risk management, and global pharmacovigilance regulations, enabling learners to play a critical role in patient safety and regulatory compliance.
Aligned with international standards such as ICH, WHO, EMA, USFDA, and MHRA, this diploma bridges scientific understanding with real-world safety operations, making graduates job-ready for careers in pharma, biotech, CROs, and regulatory organizations.
15 Months
INR 1,00,000
Intake: Year around admissions
Key Highlights
Complete understanding of global pharmacovigilance systems and safety regulations.
Learn from industry experts and drug-safety professionals with hands-on experience.
Practical exposure to case processing, signal detection, and risk-management plans.
Comprehensive modules on clinical trial safety, post-marketing surveillance, and ICSR documentation.
Integration of AI and digital tools used in pharmacovigilance workflows.
Capstone project involving a real-world pharmacovigilance case study or signal management plan.
Suitable for students and professionals in pharmacy, life sciences, medicine, or regulatory fields.
Skills You Will Learn
Adverse Event (AE) reporting and Individual Case Safety Report (ICSR) preparation.
Signal detection, risk assessment, and safety data analysis.
Regulatory compliance and documentation for global health authorities.
Pharmacovigilance data management and safety database navigation.
Clinical trial safety monitoring and expedited reporting.
Literature screening and periodic safety update reporting (PSUR/PBRER).
Communication of benefit–risk evaluations to stakeholders.
Quality control, audit readiness, and standard operating procedures (SOPs).
Tools You’ll Master
Course Outcomes
- Gain comprehensive knowledge of pharmacovigilance systems, workflow, and regulatory compliance.
- Develop the ability to process safety cases, perform signal detection, and generate safety reports.
- Understand the role of pharmacovigilance in clinical trials, post-marketing, and risk-management programs.
- Build analytical and communication skills necessary for global PV operations.
- Become employable across pharmaceutical, biotech, and contract research organizations (CROs).
Learning Outcomes
- By completing this diploma, learners will be able to:
- Perform end-to-end case processing and safety data evaluation.
- Apply international pharmacovigilance guidelines and reporting standards.
- Conduct signal detection and assess benefit–risk balance for medicinal products.
- Collaborate with cross-functional teams in clinical and regulatory operations.
- Manage documentation, audits, and inspections to maintain compliance.
Key Outcomes
- Professional certification in Pharmacovigilance & Drug Safety from Univista EdTech.
- Portfolio of applied projects including AE case studies and signal management exercises.
- Job readiness for roles such as Drug Safety Associate, PV Analyst, Case Processor, or Signal Detection Specialist.
- Strong foundation for progression into Regulatory Affairs, Quality Assurance, or Clinical Research.
- Exposure to cutting-edge digital tools and evolving AI-based pharmacovigilance platforms.
Course Curriculum
Module 1
Introduction to Pharmacovigilance and Global Drug Safety Systems
Module 2
Regulatory Guidelines – ICH, WHO, EMA, USFDA, CDSCO
Module 3
Clinical Trial Safety Management and Expedited Reporting
Module 4
Individual Case Safety Reports (ICSRs) – Collection to Submission
Module 5
Signal Detection, Evaluation & Risk Assessment
Module 6
Literature Screening, Aggregate Reporting (PSUR, PBRER)
Module 7
Safety Databases and Documentation Management Systems
Module 8
Audits, Compliance & Pharmacovigilance Quality Systems
Module 9
Automation and AI in Pharmacovigilance – Emerging Trends
Module 10
Capstone Project – Safety Audit or Signal Management Case Study
Why You Should Join this Course
- High-Demand Domain: Pharmacovigilance is one of the fastest-growing segments in global life sciences.
- Global Career Opportunities: Be eligible for regulatory-compliant PV roles across multinational pharmaceutical companies.
- Practical & Applied: Experience real-world workflows, safety tools, and case studies.
- Compliance & Innovation: Stay ahead with knowledge of AI-enabled and automation-driven drug safety practices.
- Expert-Led Mentorship: Learn directly from practicing pharmacovigilance and regulatory professionals.
- Powered by Univista EdTech: A trusted platform delivering futuristic, technology-driven, and employability-focused education, empowering professionals to ensure patient safety and regulatory excellence across the global healthcare ecosystem.
₹1,00,000
Admissions Open
Eligibility
- Minimum Qualification: 10+2 (High School) or equivalent
- Open to graduates, working professionals, and entrepreneurs
Admission Criteria
- Online application submission
- Document verification (education + ID proof)
- Admission confirmation after fee payment
