Drug Safety And Pharmacovigilance

CERTIFICATE PROGRAM IN DRUG SAFETY
AT SOLLERS

Online / In - Class Study Options

WHY DO THIS PROGRAM?

1. Studies show that Global Pharmacovigilance market is expected to reach USD 5.51 billion by 2020 , resulting in increasing demand for trained professionals in the field.
2. As more and more novel drugs are produced with large market sizes, an increasing number of expertly trained professionals are required to monitor these drugs and report adverse activities to meet international compliance and regulatory guidelines1. This program meets this high need.

WHAT WILL YOU WALK AWAY WITH?

1. Core knowledge of pharmacovigilance and drug safety, including conceptual and practical application of theories and tools used by the industry
2. Proficiency in pre and post-marketing compliance and regulations for drugs, understanding Adverse Event recognition and reporting, and Risk Management Practices
3. Experience in using Statistical Analysis and Database management tools such as Oracle Argus Safety and Empirica.

WHO IS THIS PROGRAM SUITABLE FOR?

1. Anybody with a minimum undergraduate degree from life-sciences or related backgrounds, who would like to establish or advance career in healthcare industry

Advanced Drug Safety & Pharmacovigilance

Overview:

Skills and Tools: Pre- and post-marketing compliance for drugs, Adverse Event recognition and reporting, Risk Management Practices, and Statistical Analysis and Database management using tools such as Oracle Argus Safety and Empirica.

Program Outcome: You will gain excellence in areas such as global regulatory and compliance processes, navigation of drug safety for product longevity, management and analysis of drug safety data with a competitive edge in the high-demand Drug Safety and Pharmacovigilance sector.

Program Benefits:

• Revolutionary Bootcamp for training in Drug Safety and Pharmacovigilance domain to accelerate industry careers
• 300 hours of comprehensive training including hands-on training on industry tools and case studies
• Interactive classes with industry expert faculty
• No prerequisites except your interest in learning everything about Drug Safety and Pharmacovigilance
• Possible internship & externship opportunities
• Simultaneous career guidance and networking with employers
• 81.5% placement rate across all programs that Sollers offers
• Flexible financing options
• Post-completion graduates may be eligible to transfer credits for relevant Masters Degree programs

Learning Support:

Sollers has been rigorously designed and benchmarked with the best education in this emerging field. Many of our faculty members have over 15+ years of experience in Drug Safety and Pharmacovigilance.

(Faculty info if applicable)

We offer the following forms of learning:

• Hybrid Learning Format
• Hands-on training in industry tools
• Career services and professional development support

Curriculum:

• Module 1: Introduction to Drugs, Safety and its Regulations
• Module 2: Organization and Functions of Drug Safety Department
• Module 3: Regulatory Compliance for Drug Safety and Pharmacovigilance
• Module 4: Adverse Events Reporting and Post-marketing Activities
• Module 5: Introduction to Oracle Argus Safety Application
• Module 6: Signal Detection Using Oracle Empirica

Visit Us:

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Finance Options*

Drug Safety Associate(150 hours)

DSP 601 Introduction to drug safety and its regulations 45 Hours

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on animals, clinical trials on humans, and the step of obtaining regulatory approval to market the drug. This module will educate students about the basic process of drug development and the regulatory and compliance processes that ensure consumer safety.

DSP 604 Adverse Events Reporting and Post marketing Activities 45 Hours

Pharmacovigilance assesses the safety profile of drugs. It is the science related to the collection, detection, assessment, monitoring, and prevention of the adverse effects of pharmaceutical products. Its main aim in post-marketed drugs is the increase of spontaneous reporting of adverse drug reactions. This module will provide the opportunity to understand the mechanism of the development of adverse events and the vigilance process for the event. This module analyzes the adverse events and explains adverse drug reaction in relation to the drug consumer. This module further addresses the knowledge and methods of evaluating, reviewing, and analyzing the reports of adverse events.

DSP 605 Introduction to Oracle Argus Safety Application I 45 Hours

The course provides training to the students on the features of Argus Safety, its role in fulfilling the pharmaceutical industry's toughest regulatory challenges, and how it supports drug safety business processes from an easy-to-understand user interface. Thorough case processing and discussions will allow students to gain skills regarding handling different types of cases, case processing in the software, and the highest possible quality standards to support accurate detection and analysis of drug safety signals.

Soft Skills 15 Hours