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.

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.

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.

Course Duration

Duration

5-7 Months

Engagement

300 hours

Get In Touch:

admissions@sollers.edu

or

Call Us Via:

73280 67846

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