Graduate Certificate in Advanced Drug Safety and Pharmacovigilance Program
Duration: 5-7 Months (300 hours)
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.
Why choose us?
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.
Career Guidance:
Upon program completion, we assist our students with:
• Interview Coaching
• Resume-Building Sessions
• Mock Interviews
• Job Readiness Training
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.
Testimonials
FAQ'S
What is the program's focus?
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.
How does the program combine theory and practical work?
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.
Who teaches the courses?
The instructors are professionals with over 10 years of experience in drug safety, pharmacovigilance, and related fields.
What is the teaching style?
It blends lectures, hands-on software training, and case studies, allowing students to apply theory to real-world scenarios.
How accessible are the faculty outside of class?
Faculty members are available for questions during class, and you can also reach out via email to have queries addressed.
What are typical career paths after graduation?
Graduates often pursue careers in drug safety, pharmacovigilance, regulatory compliance, and related roles in the pharmaceutical and healthcare industries.
Does the program offer career services?
Yes, career services include resume building, mock interviews, job preparation, and one-on-one sessions.
Are internships or co-op experiences available?
Yes, the program includes an internship with real-world casework.
What are the program’s prerequisites?
There are no formal prerequisites, but a background in healthcare or life sciences is beneficial.
Are standardized tests required?
No standardized tests are needed.
What is the application process and deadline?
For details on the application process and deadlines, contact admissions at 678-999-5896 or send email @ smita@myyesm.com
Is there an interview as part of the application?
No interview is required; you can join directly.
What types of financial aid are available?
EMI options and scholarships are available. For more information, contact admissions.
Are there program-specific scholarships?
Yes. Reach out to admissions for details.
What is the cost of the program?
For information on tuition costs, contact admissions at 678-999-5896 or send email @ smita@myyesm.com
Are there elective courses?
No.
What support services are available?
The program offers orientation sessions, demo classes, career discussions with industry professionals, assignments, and quizzes to assess your progress.
What is the average class size?
Classes typically have no more than 10 students, allowing for individual attention.
Are part-time or online study options available?
The program includes online sessions, and recorded lectures are provided for students who can’t attend live sessions.
Disclaimer: Yes-M Systems and/or their instructors reserve the right to make any changes to the syllabus as deemed necessary to best fulfill the course objectives. Students registered for this course will be made aware of any changes in a timely fashion using reasonable means.
