Advanced Diploma in Clinical Research & Pharmacovigilance - Genie Learning Advanced Diploma in Clinical Research & Pharmacovigilance - Genie Learning

Advanced Diploma in Clinical Research & Pharmacovigilance

With Regulatory Affairs/Medical Writing

Your Path to Success is Guaranteed

Programme Fees

₹59,000/-(Pay After Placement)

(Pay Registration fee Only)
GST will be charged at checkout View the payment plan

Duration

6 Months

(500 + Hours)

(Course includes theoratical, Practicle, Assignments and Projects)

Giving students the ability to pursue their dreams

Genie Learning enables students to achieve their aspirations by offering Pay After Placement, allowing them to focus on their education without financial stress. Our Global Curriculum equips students with internationally recognized skills, while Senior Industry Trainers provide expert guidance and real-world insights. Through specialized Software Training and hands-on Industry Internships, students gain practical experience, bridging the gap between academic learning and professional application. Together, these elements create a comprehensive learning environment that fully prepares students for successful and fulfilling careers in clinical trial industry.

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Program Advantage

Our comprehensive program in Clinical Research, Pharmacovigilance, and Clinical Data Management offers an immersive learning experience tailored for your success in the clinical research industry. Through flexible online learning, you’ll delve into essential topics such as study design, data management, regulatory compliance, adverse event monitoring, and safety reporting. The curriculum integrates advanced Artificial Intelligence and software training, keeping you at the forefront of technological advancements in healthcare. Learn from senior industry trainers and gain invaluable hands-on experience through structured industry internships. With our robust Guaranteed Placement support, and Pay After Placement options, we ensure you are fully prepared and connected to secure a rewarding career in healthcare and pharmaceuticals.

Global Curriculum

Adopting a global Clinical Trials curriculum enhances your expertise, making you competitive in the international research field.

E-Learning

Embrace online learning for flexible access to expert instructors and practical skills, making education adaptable and convenient.

Artificial Intelligence

Master AI in Clinical Trials to enhance efficiency, accuracy, and outcomes, making a significant impact in the field.

Industry Internship

Boost your career, become job-ready, and get hired by enhancing skills through our comprehensive industry internship program.

Senior Industry Trainers

Leverage senior industry trainers for deep insights and advanced skills, ensuring you gain valuable real-world expertise.

Guaranteed Placement Support

Unlock Your Future with Our “Pay After Placement” Guarantee! Secure your dream job first, then pay from your salary.

Course Module

Clinical Research

  • Drug Discovery & Development
  • Overview of Clinical Research
  • Regulations & Guidelines in Clinical Research
  • Roles & Responsibilities of Key Stakeholders
  • Preparation & Planning of Clinical Trials
  • Essential Documentation in Clinical Research & Regulatory Submission
  • Study Start-Up Process
  • Clinical Monitoring Essentials
  • Compliance, Auditing & Quality Control in Clinical Research
  • Hands-On Software Training

Pharmacovigilance

  • Overview of Clinical Research
  • Pharmacology – General Principles
  • Introduction to Pharmacovigilance
  • Pharmacovigilance Regulations
  • Hands-on Training in Case Processing and Report Generation
  • Safety Reporting and Processing ICSR
  • Aggregate Reports, Signal Detection & Risk Management
  • Documents in Pharmacovigilance
  • Audits & Inspections
  • Advanced Pharmacovigilance & Analytics
  • Hands-On Software Training

Regulatory Affairs

  • Introduction to Regulatory Affairs

  • Drug Development Process

  • Regulatory Submissions

  • Good Clinical Practice (GCP) and Ethics

  • Regulatory Strategy and Intelligence

  • Quality Assurance & Compliance

  • Risk Management in Clinical Trials

  • Post-Marketing Regulatory Requirements

  • Communication & Collaboration

  • Current Trends and Future in Regulatory Affairs

  • Career Development in Regulatory Affairs

Medical Writing

  • Introduction to Medical Writing

  • Basics of Clinical Trials

  • Data Collection & Management

  • Regulatory Writing

  • Scientific Writing

  • Data Presentation and Interpretation

  • Writing for Different Audiences

  • Ethics and Compliance in Medical Writing

Artificial Intelligence for Clinical Trial

  • Consideration Introduction to AI in Clinical Trials
  • AI Technologies and Tools
  • AI in Clinical Trial Design
  • AI in Clinical Data Management
  • AI in Safety and Pharmacovigilance
  • Machine Learning Basic
  • Machine Learning Algorithms
  • Natural Language Processing
  • Ethical & Regulatory Consideration
  • Future Trends and Innovations
  • Hands-on Projects

Pre-Placement Training

  • Resume and CV Building
  • Cover Letter Writing
  • LinkedIn and Professional Networking
  • Interview Preparation
  • Communication Skills
  • Soft Skills and Professional Etiquette
  • Industry Insights and Networking
  • Final Assessment and Feedback
  • Industry-Specific Case Studies

Our mission is to provide more accessible & Quality education

At Genie Learning, we believe in putting your success first. That’s why we offer a ‘Pay After Placement’ program, where the financial risk is entirely on us. This allows you to concentrate on enhancing your skills and knowledge without the stress of high upfront fees. Focus on mastering the field of clinical research, and only pay once you’ve secured a job. Start your journey with us today—your future begins here!

Risk-Free Learning

You only pay registration fee and rest once you’ve secured a job, minimizing financial risk and ensuring the training delivers real results.

Guaranteed Placement

You pay the remaining fee only after landing a job, ensuring that your investment directly results in employment, providing peace of mind and financial security.

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