Graduate Certificate in Advanced Drug Safety and Pharmacovigilance Program
Unique program designed for professionals aspiring to make a career in Drug Safety using the in-demand, industry-based Oracle Argus Safety Database Software.
OVERVIEW
Why Drug Safety and Pharmacovigilance?
“Safety isn’t expensive; it is priceless.” Therefore, Pharmacovigilance has become the prime focus in the healthcare industry to optimize benefits and risks. Sollers College’s Advanced Drug Safety and Pharmacovigilance Programs cater to the needs of this ever-growing and highly regulated industry by offering a curriculum aligned with the real-time industry requirements, highly competent, and equips career readiness for professionals seeking a career in the pharmaceutical industry.
In This Course
This program provides a thorough understanding of the drug development process and its life cycle, regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others. This program educates students about the business dynamics of the pharmaceutical industry. Students gain a thorough understanding of adverse events and adverse drug reactions (ADRs), AE evaluation, AE reporting dynamics, MedWatch forms, and ICSR processing. Hands-on 12-week internship training on the industry-based Oracle Argus Safety database. In the internship, students develop the ability to triage the assigned cases according to industry standards.
The Sollers Advantage
The highlight of this advanced program is the 12-week In-house Internship on the latest high demand tool, Oracle Argus 8.1.2. Students work in different roles in our internship program to acquire knowledge and become job-ready from day 1. They process all types of cases that include literature, valid, spontaneous, clinical trials, invalid, serious, non-serious, at risk, and lack of efficacy cases.
HIGHLIGHTS
Proficient Instructors: Experts with 15+ years of industrial experience guiding students and providing real-time examples and scenarios.
Software and Tools: Get in-depth knowledge of Argus 8.1.2
Internship Program: 12-week internship program inclusive of Oracle Argus Software and Hands-on training in Aggregate Reporting.
Curriculum: Job-oriented, industry-based curriculum aligned with the current scenario with full-fledged access to program content, batch recordings, and tools after one year of program completion.
Certification: Two certificates – a course completion certificate and internship completion.
Career Guidance: Our career service advisors provide guidance for the resume and interview preparation.
References: References for the jobs as a Drug Safety Associate Intern.
LEARNING OUTCOMES
Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.
Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments
Practice the processes of triage, data entry, medical review, statistical analysis, implementation of REMS (Risk Evaluation and Mitigation Strategy), Phase IV surveillance trials, Regulatory Writer for Labels, and Pharmacovigilance Strategy, as well as reporting through the Oracle® Argus software
Internship in Oracle Argus Software – In this 12-week internship phase, students achieve practical experience in processing ICSRs from book-in to distribution along with writing case narrative using Oracle Argus 8.1.2. And work on real time live cases.
Hands-on experience of working on coding for medical history, ADRs using WHO drug dictionary and MedDRA.
Expertise in regulatory report writing like ISS/ISE, ICSR, PSUR, PBRER, SUSAR, aggregate reports and others as required for various regulatory compliance.
SYLLABUS
To get the complete syllabus, please login with your email ID.
INSTRUCTORS
Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.
Course Duration
Duration
5-7 Months
Engagement
300 hours
For information regarding fee and/or reserving your spot, contact our Admissions Team.
Credit transfers applicable for alumni
Career Guidance
After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.
We provide exclusive one-on-one sessions with our industry-based career advisors who provide guidance right from resume feedback, assisting with interview Q&As, and helping with job preparations.
Student Testimonials
Campus Visit
FAQs
This is a 300 Hour program
- Bachelor in Health Care or Life Sciences background
The exclusive training institute to take real time, hands-on training on Pharma world’s most acclaimed and advanced Oracle Argus Safety software under the guidance of industry experts.
Federally and N J state accredited and approved curriculum at modern institute with advanced video sharing white boarding, flexible schedules with facility of remote-distance learning along with in-class sessions.
Drug safety professionals are always in short supply due to increasing regulatory compliance needs to maintain Safety of each marked product for every pharmaceutical company.
Constant expansion of the market due to new drugs entering the market.
Yes. Internship provides an excellent opportunity for practical hands-on working experience on virtual life like functionality of various Reporting functions for Drug safety and Pharmacovigilance.
Certificate of Completion in Advanced Drug Safety and Pharmacovigilance Program.
Submissions of assignments, quizzes, and surveys along with financial obligation towards the college is mandatory for processing and issuing of certificate.