Graduate Certificate in Advanced Drug Safety and Pharmacovigilance Program
Elevate your Drug Safety expertise with our unique program, designed to equip you with hands-on experience on the in-demand Oracle Argus Safety Database Software.
Program Overview
Our program provides a comprehensive understanding of the drug development lifecycle, from initial discovery to market launch. You’ll delve into global regulatory requirements, including FDA, EMA, and ICH guidelines. Additionally, you’ll gain insights into the business dynamics of the pharmaceutical industry.
Hands-on Training with Oracle Argus
Our 12-week in-house internship on Oracle Argus 8.1.2 offers practical experience in adverse event management. You’ll learn to validity of cases, triage of cases, categorization and listedness of cases using SmPC, PI or CCDS of Innovator companies, medical coding using MedDRA, process and analysis of adverse drug reactions (ADRs) from various sources like spontaneous databases, literature, ADR reporting forms, and from regulatory authority of US, EU and Non-EU countries. This hands-on training prepares you for real-world roles in the pharmaceutical industry.
Learning Outcomes
Pharmacology Expertise
Understand drug actions, pharmacokinetics, pharmacodynamics, and drugs acting on various systems (CNS, PNS, cardiovascular, etc.).
Drug Discovery & Development
Learn the entire drug development process, from discovery to clinical trials, with insights into AI applications and bioequivalence testing.
Pharmacovigilance Skills
Master ADR reporting, causality assessment, ICSR processing, and aggregate reporting, following global regulatory frameworks (WHO, FDA, EMA).
Statistical & Epidemiological Competence
Gain proficiency in biostatistics, hypothesis testing, parametric/non-parametric tests, and safety data analysis using tools like Excel, Prism, and R.
Pharmacoepidemiology & Pharmacoeconomics
Understand pharmacoeconomic analyses, cost-effectiveness models, and health technology assessments to evaluate drug safety and efficacy.
Hands-On Application
Develop practical skills with Oracle Argus Safety software, systematic literature reviews (SLR), and meta-analysis using RevMan and R.
Why Choose Us?
In-house Internship
Proficient Instructors
Industry-based curriculum
24 x 7 Lifetime Support
Expertise in Oracle Argus 8.1.2
Two Certificates (Course & Internship)
Career Guidance
Upon program completion, we assist our students with:
Our exclusive one-on-one sessions with industry-based career advisors provide guidance in resume feedback, interview Q&A assistance, and job preparation support to help you confidently enter the corporate world.
Program-Specific FAQs
Find answers to common questions about the Drug Safety and Pharmacovigilance program.
It focuses on Drug Safety and Pharmacovigilance, covering the entire lifecycle of drug safety—from development to post-marketing activities—and includes hands-on training with Oracle Argus Safety software.
The program balances theoretical knowledge (e.g., drug development and regulatory compliance) with practical, hands-on experience, including training on Oracle Argus Safety and an internship.
The instructors are professionals with over 10 years of experience in drug safety, pharmacovigilance, and related fields.
It blends lectures, hands-on software training, and case studies, allowing students to apply theory to real-world scenarios.
Faculty members are available for questions during class, and you can also reach out via email to have queries addressed.
Graduates often pursue careers in drug safety, pharmacovigilance, regulatory compliance, and related roles in the pharmaceutical and healthcare industries.
Yes, career services include resume building, mock interviews, job preparation, and one-on-one sessions.
Yes, the program includes an internship with real-world casework.
There are no formal prerequisites, but a background in healthcare or life sciences is beneficial.
No standardized tests are needed.
For details on the application process and deadlines, contact admissions at 678-999-5896 or send email @ smita@myyesm.com
No interview is required; you can join directly.
EMI options and scholarships are available. For more information, contact admissions.
Yes. Reach out to admissions for details.
For information on tuition costs, contact admissions at 678-999-5896 or send email @ smita@myyesm.com
No.
The program offers orientation sessions, demo classes, career discussions with industry professionals, assignments, and quizzes to assess your progress.
Classes typically have no more than 10 students, allowing for individual attention.
The program includes online sessions, and recorded lectures are provided for students who can’t attend live sessions.