Graduate Certificate in Drug Safety and Pharmacovigilance Training 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 Drug Safety and Pharmacovigilance Training 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 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. Students gain thorough understanding of the adverse events and adverse drug reactions (ADRs), AE evaluation,dynamics of AE reporting, medwatch forms, and ICSR processing.Students are given full fledged knowledge and access to Oracle Argus Safety database along with sample cases.

The Sollers Advantage

The highlight of this program is the hands-on access to the latest and high in-demand safety database tool used by the pharmaceutical industry, Oracle Argus 8.1.2. Our Program provides practical experience of using the Argus Safety database. The 3-month certificate course is designed and taught by faculty with experience in the industry.

Learning Outcomes

  • This course is based on the FDA guideline on Good pharmacovigilance practices (GVP) and is a complete training solution to acquire pharmacovigilance knowledge.
  • Gain expertise in Clinical Research, Drug Development, Clinical Trial Design and Clinical Development.
  • Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.
  • Develop advanced knowledge of various functionaries in Drug Safety departments.
  • Practice the processes of triage, data entry, medical review, Phase IV surveillance trials, as well as reporting through the Oracle Argus software.
  • Detailed training in MedDRA coding and medical narrative writing for SAE reports.

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.

Curriculum:

Job-oriented, industry-based curriculum, full-fledged access to program content, batch recordings, and tools up to one year of program completion.

Certification:

Students will receive course 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.

Clinical Trials Course Modules

Drug Development Process
Introduction, Pharmacokinetics
Drug Receptors: Pharmacodynamics
PK-PD and Drug Dosing, Time Action
Drug Biotransformation
Drug Development and Regulations
Ethics of Human Subjects Protection
Historical Perspective: Human Research
Clinical, Genetic and Vulnerable Group
Ethics and Federal Regulations
FDA Regulated Research and GCP
Institutional Responsibility and HIPAA
Good Clinical Practice in Clinical Trials
Understand Good Clinical Practice
ICH E6 Guidelines

Ethics, Honesty, and Business Dynamics at Play
Ethics and Honesty in Pharmaceutical Industry
Business Dynamics of Safety Agencies
Dynamics in Various Actions and Functions
Clinical Trial Outcomes
Sales and Marketing Strategy
Understand Drug Safety Department
Triage, Data Entry, Case Generation Units
Quality Medical Review Functions
Quantity-Statistical Review Functions
Case Processing, Reports, and Transmission
Pharmacovigilance, SOP, REMS: Action Units
Training in Drug Safety Career for New Hire
Understand Company SOP and Functions
Core and Safety Databases, Linkages
Safety Reports from Clinical Trials
Safety Maintenance in Open Market-Phase IV
Actions: Labels, Warnings, Specialty Issues

Pharmacovigilance and Regulatory Needs
WHO: Pharmacovigilance Initiatives
FDA: Good Pharmacovigilance Practices
Roles of Various Agencies in Pharmacovigilance
Emphasis on Healthcare Providers, Consumers
US FDA: Regulatory Scenario
FDA Premarketing Risk Assessment Guidance
FDA/ICH: NDA-CTD: Post-market B/R Guidance
FDA: Risk Evaluation Mitigation Strategy
FDA: PhV and Ph Epidemiology Guidance
FDA: PhV Audits, Reports, Compliance Guidance
Europe, ICH, CIOMS, and International Regulatory Scenario
Role of CIOMS Guidance and Reports
ICH Guidelines
Recent Advances in EU Guidelines

Adverse Events-1 in Details
Adverse Events: Definition and Types
Premarket Toxicology and AE Establishment
Methods to Evaluate Adverse Events
Adverse Events-2 Med Watch, Voluntary Reports
Understand the Role of MedWatch Forms
Comparison of Pre- and Post- market Reporting
Company Dynamics of AE Reporting to FDA
Importance and significance of voluntary reports
Need to Follow-up and Completion of Reports
Adverse Events-3 Triage and ICSR Generation
Importance of Patient -Reporter Details in ICSR
Importance of Product Details in ICSR
Importance of Event Details in ICSR
Science of Adverse Event evaluations

• Pharmacovigilance Overview
• Regulatory Guidelines
• Argus Safety Overview
• Argus Safety Database
• Argus Affiliate
• Argus Features
• Argus Main Components
• Worklist Management
• Case Processing in Argus Safety
• ICSR Overview
• MedDRA and WHO-DD Overview
• WHO-DD
• Case Narrative
• Linking of Cases in Argus Safety
• Hands-on Training of Entry of Various Types of Cases in Argus Safety Database

• Signal Detection Overview
• Empirica Signal Introduction
• Creating Data Mining Runs
• Results of Runs
• Statistical Reports Generation
• Data Mining Runs
• Report Interpretation
• Sector Map Overview
• Identification of Signal
• Empirica Topics and Workflow Configuration
• Setting Preferences
• Navigating With Tabs
• End User Training
• Compliance Requirement
• Master in Data Mining Runs and Sector Map

  • 1. Introduction to Clinical Trials
  • 2. Regulatory Framework
  • 3. Roles and Responsibilities
  • 4. Phases of Clinical Trials
  • 1. Investigational Product Management
  • 2. Protocol Development
  • 3. Patient Safety and Monitoring
  • 4. Site and Trial Management
  • 5. Trial Oversight
  • 1. Clinical Data Management
  • 2. Electronic Data Capture (EDC) Systems
  • 1. Introduction to Clinical Trial Operations
  • 2. Advanced Functions of CTO
  • 1. Clinical Project Management Basics
  • 2. Advanced Project Management
  • 1. Regulatory Affairs
  • 2. Medical Writing
  • 1. Epidemiology and Public Health
  • 2. Biostatistics
  • 1. SAS Programming for Clinical Trials
  • 2. Advanced Data Analytics
  • 1. Decentralized Clinical Trials (DCT)
  • 2. Digital Health Technologies
  • 1. Real-World Evidence (RWE)
  • 2. Patient-Centric Trials
ORACLE ARGUS INTERNSHIP

Elevate Your Skills With Our 12-Week In-House Internship And Master The Latest Highly Demanded Must-Have Tool, Oracle Argus 8.1.2!

CAREER SUPPORT

Experts With Over 15 Years Of Professional Industrial Expertise Guiding And Coaching Students To Polish Their Resumes And Prepare For Interview Success!

LINEAGE OF A DECADE

For More Than 10 Years Sollers College Has Been Paving The Way For Education Offering Top Notch Insightful Programs Along With A Broad Alumni Network For Engagement.

Drug Safety Pharmacovigilance Career Opportunities

  • Drug Safety Associate/Pharmacovigilance Associate
  • Clinical Safety Scientist/Manager
  • Signal Detection Analyst
  • Aggregate Reporting Specialist
  • Pharmacovigilance Compliance Specialist
  • Risk Management Specialist
  • Pharmacovigilance Trainer
  • Pharmacovigilance Project Manager
  • Regulatory Affairs Specialist
  • Medical Writer

Course Duration

Duration

7-8 months

Engagement

300 hours

Program Mode

Hybrid

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

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