Your Pathway to Becoming a Pharmacovigilance Scientist

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