Your Pathway to Becoming a Pharmacovigilance Scientist

Transition seamlessly from healthcare to pharmacovigilance with a program designed to unlock your career potential in just five weeks.

Program Structure

Week 1: Introduction to Pharmacovigilance and Core Concepts

Class 1: Fundamentals of Pharmacovigilance

  • Overview of pharmacovigilance principles and its role in public health.
  • Key terminologies and workflows in drug safety.

Class 2: Individual Case Safety Reports (ICSR) and MedDRA Coding

  • Types of reports: spontaneous, solicited, and literature cases.
  • Introduction to MedDRA coding and its application in case processing.



Week 2: Adverse Event Reporting and Assessment

Class 1: Causality Assessment

  • Techniques for determining the relationship between drugs and adverse events.
  • Tools and methodologies for effective assessment.

Class 2: Literature Surveillance

  • How to conduct systematic reviews of scientific literature for drug safety information.
  • Best practices for capturing reportable adverse events from literature sources.



Week 3: Advanced Reporting and Signal Detection

Class 1: Aggregate Reports

  • Introduction to periodic safety update reports (PSUR) and periodic benefit-risk evaluation reports (PBRER).
  • Best practices for compiling and interpreting aggregate data.

Class 2: Signal Detection and Management

  • Signal identification using data mining techniques.
  • Overview of tools like Empirica Signal for automated detection and analysis.



Week 4: Risk Management and Compliance

Class 1: Risk Management Plans (RMP), REMS, and ETASU

  • Developing risk management strategies and regulatory compliance.
  • Understanding Elements to Assure Safe Use (ETASU) in Risk Evaluation and Mitigation Strategies (REMS).

Class 2: Risk Classification and Safety Management Plan

  • Techniques for classifying risks and designing comprehensive safety management plans.
  • Case studies on effective risk mitigation strategies.



Week 5: Audits, Leadership Development, and Career Preparation

Class 1: Pharmacovigilance Audits and RECIST Criteria

  • Preparing for and managing pharmacovigilance audits.
  • Introduction to RECIST criteria for evaluating responses to treatment.

Class 2: Leadership Skills and Mock Interviews

  • Building critical leadership abilities for career advancement.
  • Simulated interviews with expert feedback tailored to pharmacovigilance roles.



Tangible Benefits:

  • ✔ Career Readiness in 5 Weeks
  • ✔ Resume and Interview Prep
  • ✔ On-the-Job Support

Career Benefits:

  • 💼 100% Remote Work Opportunities
  • 💼 Salary Potential: $150,000 - $180,000

Special Launch Offer: $2,450 (Save 50%)