Post Graduate Diploma in Drug Safety and Pharmacovigilance

Work with the latest industry tools and learn how to apply them in the domain of Drug Safety and Pharmacovigilance.

Overview

Why Drug Safety and Pharmacovigilance

Pharmacovigilance has become the prime focus in the healthcare industry to ensure that the right products reach the patients at the right time with optimized benefits and risks. With a surge in the pharmaceutical industry’s advancements, regulatory authorities there is a growing need for qualified professionals for the pharmaceutical industry, regulatory authorities, and academia.

In This Course

Students will gain a thorough understanding of E2E Pharmacovigilance processes, Concepts of the drug life cycle, Guidelines and regulations, adverse events and adverse drug reactions (ADRs), aggregate reporting through Oracle Argus 8.1.2 Safety database application, Project Management, and Literature Review, Internship in Oracle Argus Software, Electronic Trial Master File documentation (eTMF) tool, CTMS, and Capstone Project.

The Sollers Advantage

- E2E comprehensive program that covers PV concepts and clinical research
- Access to Oracle Argus Safety database 8.1.2, CTMS and ETMF systems based on elective selection
- During their internship sessions for all types of cases, students work in several positions simulating Pharmaceutical roles.
- Capstone Project during the final semester to demonstrate a practical understanding

Learning Outcomes

  • Students gain a thorough understanding of the adverse events and adverse drug reactions (ADRs).
  • Training for triage of Adverse Events and Serious Adverse Event, aggregate reporting through Oracle Argus 8.1.2 Safety database application.
  • Know the process of coding with MedDRA and medical narrative writing.
  • Hand on experience on Oracle Argus Software.

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., and CTMS & ETMF tools based on elective selection.

Internship Program:

Internships in PV and Clinical Trial Management inclusive of hands-on training in Aggregate Reporting based on elective selection.

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 certificate.

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

2 Years

Get In Touch:

admissions@sollers.edu

or

Call Us Via:

73280 67846

Become a Certified
Clinical Trials Manager
Fast-track Your Life Sciences Career

100% Online | Industry-Driven Curriculum | Career Support Included

black
ISO Certified
flags
US Faculty
medal
10+ Years of Excellence