Drug Safety Data Management Certification and Pharmacovigilance Training
Category:
Drug Safety
 
Duration:
16 Weeks / 380 Hours
 
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DRUG SAFETY – MEDICAL REVIEWER

Introduction – Drug Safety (Medical Reviewer)

“At Qtech-Sol, we lead the way in Clinical Science Training, offering specialized programs tailored to individuals with aspirations of thriving in meaningful careers as Drug Safety Associates (DSAs) or Drug Safety Coordinators (DSCs). Our programs are meticulously designed to provide a comprehensive educational experience, equipping you with the essential knowledge and hands-on skills necessary for excelling in these pivotal roles.

As a Drug Safety Associate, your role is of paramount importance in ensuring the safety and well-being of patients participating in clinical trials and individuals using pharmaceutical products in real-world settings. Your responsibilities encompass a wide array of functions that are indispensable to the pharmaceutical and healthcare industries.”

Course Name :  Drug Safety (Medical Reviewer)
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  DSMR
Course Material : This course contains and delivers 54 Lessons.

Course Overview: This comprehensive program consists of lessons, organized into three distinct modules, designed to be completed over a span of 16 weeks.

  1. DSAT – Basic Drug Safety Associate Training: This module includes lessons delivered in various formats, such as narrated presentations, course reading materials (chapters), quizzes for practice (15 sets), tests (10 sets), short questions, and role-based tasks with accompanying solutions.
  2. DSAP – Drug Safety Associate Projects: In this module, lessons are primarily presented in a narrated presentation format, along with role-based tasks and their respective solutions.
  3. ADSA – Advanced Drug Safety Associate Lessons: The ADSA module also offers lessons in narrated presentation format, supplemented by role-based tasks and solutions.

This program structure ensures a comprehensive learning experience, allowing students to build a strong foundation and progress to more advanced topics in the field of drug safety.

Delivery Type

SIP – Self-Paced Online with Support

Course Duration

DSMR-SIP Delivery – 16 Weeks / 380 Hours (Self-Paced)

Introduction

Our comprehensive training programs cater to individuals aspiring to excel in the dynamic field of drug safety and pharmacovigilance. These programs are meticulously designed to equip you with the knowledge, skills, and expertise needed to thrive in the role of a Drug Safety Associate (DSA) or Advanced Drug Safety Associate (ADSA). Additionally, our Drug Safety Associate Projects (DSAP) module provides practical insights and hands-on experience to complement your learning journey. Let’s delve into the details of each program:

DSAT – Basic Drug Safety Associate Training: The DSAT program serves as the foundational stepping stone for your career in drug safety. It comprises a well-structured curriculum consisting of 54 lessons, carefully organized into three distinct modules. Throughout 16 weeks of immersive learning, you will explore narrated presentations, course reading materials, practice quizzes, tests, short questions, and role-based tasks with solutions. DSAT ensures you build a robust foundation in drug safety fundamentals, setting the stage for your progression into more advanced roles.

ADSA – Advanced Drug Safety Associate Lessons: As you advance in your career, our ADSA program offers specialized training in advanced drug safety practices. This module builds upon the knowledge acquired in the DSAT program, providing in-depth insights into complex topics within the field of drug safety. You’ll engage with narrated presentations, role-based tasks, and solutions, refining your expertise and preparing you to take on leadership roles in pharmacovigilance and adverse event management.

DSAP – Drug Safety Associate Projects: Practical experience is invaluable in the world of drug safety. Our DSAP module bridges the gap between theory and real-world application. Through this program, you will have the opportunity to work on projects that mirror the challenges faced by drug safety professionals. This hands-on experience, guided by experienced mentors, allows you to apply your knowledge and problem-solving skills, making you job-ready and well-prepared for the complexities of the pharmaceutical industry.

In summary, our DSAT, ADSA, and DSAP programs offer a comprehensive educational journey tailored to your career aspirations in drug safety. Whether you are just starting your journey or seeking advanced expertise, our training programs provide the tools you need to excel in the dynamic and critical role of a Drug Safety Associate.

Course Enrollment process

Qtech-Sol offers a flexible approach to learning through our self-paced online courses. Students have the freedom to commence their studies at their convenience, following a straightforward process.

  1. Member Registration: Begin by registering as a member of our platform
  2. Course Selection: Explore and choose the course that best suits your needs and goals.
  3. Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
  4. Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
  5. Support and Assistance: Receive support and assistance via email or schedule Google Meet sessions through the LMS.
  6. Course Task Submissions: Submit course-related tasks and assignments as per the provided schedule.
  7. Final Examination: Upon finishing the course, take the final examination to demonstrate your understanding.
  8. Course Completion: Upon successful completion, receive a course completion certificate and a transcript.
  9. Post-Training Support: Take advantage of our post-training support for assistance with resume building, narrative development, and mock interviews.

This step-by-step process ensures a smooth and flexible learning experience, allowing you to acquire valuable skills and knowledge at your own pace.

Building Relevant Experience

Embarking on a fulfilling career as a Drug Safety Associate (DSA) requires a strong foundation in life sciences or closely related health disciplines, such as Pharmacy, Medicine, Nursing, or PharmD. However, it’s important to note that certain entry-level positions, like Drug Safety Assistants (DSAs), may only require an associate degree or, in specific cases, a high school diploma.

At Qtech-Sol, our DSA Program goes beyond the basics, focusing on advanced computer-based roles that harness clinical data and tools to ensure patient safety during clinical trials. Proficiency in essential computer applications such as Microsoft Word, Excel, Notepad, and PowerPoint is a fundamental prerequisite for success in this dynamic field.

Our program is designed for candidates with backgrounds in pharmaceuticals, healthcare, or research centers, including hospitals. We place significant emphasis on the advanced responsibilities carried out by Drug Safety Associates, who are tasked with the meticulous monitoring and evaluation of adverse events and side effects linked to drugs and medical products. Our students gain hands-on experience and exposure to real-world practices and case studies, covering critical areas such as pharmacovigilance, regulatory compliance, signal detection, risk assessment, and data management. Furthermore, students become well-versed in Good Pharmacovigilance Practice (GVP) guidelines, International Council for Harmonisation (ICH) standards, and the regulatory landscape governing pharmacovigilance.

Upon successfully completing our program, individuals open doors to a range of job titles in the drug safety arena, including but not limited to:

  1. Pharmacovigilance Manager
  2. Drug Safety Officer
  3. Senior Pharmacovigilance Scientist
  4. Pharmacovigilance Team Lead
  5. Pharmacovigilance Operations Manager
  6. Pharmacovigilance Quality Assurance Specialist
  7. Pharmacovigilance Data Analyst
  8. Pharmacovigilance Compliance Manager
  9. Signal Detection Scientist
  10. Medical Reviewer
  11. Risk Management Specialist
  12. Pharmacovigilance Auditor
  13. Drug Safety Consultant
  14. Pharmacovigilance Trainer/Educator
  15. Pharmacovigilance Project Manager
  16. Drug Safety Project Coordinator
  17. Pharmacovigilance Systems Analyst
  18. Pharmacovigilance Business Analyst
  19. Clinical Safety Scientist
  20. Pharmacovigilance Analytics Manager

Our comprehensive training equips aspiring professionals with advanced skills and knowledge necessary to excel in the pivotal role of a Drug Safety Associate, ensuring patient safety and upholding the highest standards in the pharmaceutical and healthcare industries.”

Educational Requirements:

Preferred Qualifications: To excel in roles within Drug Safety, candidates should hold an associate degree for entry-level data entry positions, while a bachelor’s or master’s degree in various science-related fields is highly recommended for more advanced roles. Eligible majors for enrollment span a diverse spectrum of disciplines, including Medicine, Nursing, Pharmacy, Public Health, Chemistry, Pharmacology, Pharmaceutical Chemistry for Drug Safety Associate roles, and Medical Reviewer or Drug Safety Physician positions.

Support After Training:

Your resume is often the first impression you make on recruiters and potential employers. In today’s competitive job market, it’s crucial to ensure that your resume meets industry standards and effectively represents your qualifications. That’s where our Post-Training Assistance (PTA) program comes in.

Our PTA program offers valuable assistance in resume building, interview preparation, and mock interviews. It’s not just about creating a strong resume; it’s also about understanding the current job market in your area, identifying available positions, gauging salary ranges, and ensuring that your resume aligns with your career goals. During the PTA program, you’ll have the opportunity to engage with our course specialists, taking small but meaningful steps toward your professional success. We’ll work together as a team to help you achieve your career objectives.

   Key Learning Outcomes and Benefits for Students:

  1. Enhancing the knowledge and skills required for your field.
  2. Improving your resume to increase your chances of landing promising job opportunities.
  3. High-value learning at an affordable cost.
  4. Flexibility to learn from anywhere, at your own pace.
  5. Practical tasks aligned with real-world industry practices and job roles.
  6. Application of concepts in real-time scenarios, including policies, governance, and industry tools.
  7. Engaging in role-based tasks commonly practiced in the industry.
  8. Preparation with mock interviews and interview narratives for effective client discussions.
  9. Readiness to work with minimal support, boosting your confidence in your chosen field.
Professional Organizations and Associations:

Drug Information Association (DIA): DIA is a global organization that brings together professionals from various pharmaceutical and healthcare sectors, including Drug Safety and Pharmacovigilance. Becoming a member provides access to conferences, webinars, and networking events.

International Society of Pharmacovigilance (ISoP): ISoP is a specialized organization dedicated to Pharmacovigilance professionals. Joining ISoP offers opportunities to connect with experts, attend conferences, and access their journal, Pharmaceutical Medicine.

American Society of Safety Professionals (ASSP): ASSP focuses on occupational safety and health but is relevant for those in Drug Safety. Membership grants access to resources, publications, and events to enhance your knowledge and network.

Regulatory Affairs Professionals Society (RAPS): RAPS is essential for professionals involved in regulatory aspects of Drug Safety. Joining RAPS provides access to regulatory knowledge and networking opportunities.

Stay Informed:

  1. Pharmaceutical Journals:Regularly read industry journals such as “Drug Safety,” “Pharmacoepidemiology and Drug Safety,” and “Journal of Pharmacovigilance” to stay updated on research, regulations, and trends.
  2. Clinical Trial Websites: Explore websites like ClinicalTrials.gov and the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) for the latest clinical trial information and updates.
  3. FDA and EMA Websites: Stay informed about regulatory updates by regularly visiting the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) websites.
  4. Pharmaceutical News Sources: Subscribe to pharmaceutical news sources such as PharmaTimes, Pharmaceutical Executive, and FiercePharma to receive industry updates and insights.
  5. LinkedIn and Professional Networks: Join LinkedIn groups and professional networks related to Drug Safety and Pharmacovigilance to engage in discussions, share knowledge, and stay updated through peer interactions.
  6. Conferences and Webinars: Attend industry-specific conferences, webinars, and seminars to gain firsthand knowledge about the latest developments in clinical trials, regulatory matters, clinical data management, and pharmacovigilance.

By actively participating in these professional organizations, staying informed through various resources, and networking within your field, you can enhance your career prospects and remain up-to-date with the dynamic landscape of Drug Safety and Pharmacovigilance.

Overview of the Curriculum

Our Drug Safety Professional Master (DSPM) program encompasses three integral training modules: Basic Drug Safety Associate Training (DSAT), Advanced Drug Safety Associate Lessons (ADSA), and Drug Safety Associate Projects (DSAP). This comprehensive curriculum is designed to empower individuals aspiring to excel in the dynamic field of drug safety and pharmacovigilance, offering a progressive learning experience to cater to all career stages and aspirations.

Drug Safety – Medical Reviewer Lessons
DSAT – Basic Drug Safety Associate Training: DSAT serves as the fundamental cornerstone of the DSPM program, providing a structured foundation in drug safety essentials. Comprising 22 lessons divided into three modules, this program spans 16 weeks of immersive learning. The curriculum incorporates a variety of learning formats, including narrated presentations, course reading materials, practice quizzes, tests, short questions, and role-based tasks with solutions. DSAT equips you with the foundational knowledge and skills required to embark on a rewarding career as a Drug Safety Associate.

1. Introduction to Clinical Research: Gain a foundational understanding of the clinical research landscape, setting the stage for your journey in Drug Safety.

2. Drug Development Process: Explore the intricate process of drug development, from discovery to market approval.

3. Introduction to Drug Safety / Pharmacovigilance: Delve into the fundamental concepts of Drug Safety and Pharmacovigilance, essential for the role.

4. Role of DSA / PVA (Trials): Understand the pivotal role of Drug Safety Associates/Coordinators in clinical trials.

5. Introduction to Adverse Events: Learn about adverse events and their significance in Drug Safety.

6. ICH-Good Clinical Practice Guidelines: Familiarize yourself with the ICH-GCP guidelines, a cornerstone of clinical research ethics and quality standards.

7. Drug Safety Regulation and Guidelines: Navigate the regulatory landscape governing Drug Safety.

8. Overview of the Clinical Trial Protocol: Explore the critical elements of a clinical trial protocol and its relevance to Drug Safety.

9. Characteristics of a Case: Understand the key characteristics of cases in Drug Safety reporting.

10. Sources of Individual Case Reports: Explore the various sources of individual case reports and their significance.

11. Drug Safety Data Extraction and Pre-Processing: Master the art of extracting and pre-processing Drug Safety data.

12. SOP Development: Learn the importance of Standard Operating Procedures (SOPs) in ensuring consistent and compliant processes.

13. Communication with Cross-Functional Teams: Enhance your communication skills for effective collaboration with cross-functional teams.

14. Understanding 21 CFR Part 11 and HIPAA: Gain insights into regulatory compliance with 21 CFR Part 11 and HIPAA regulations.

15. Basics of Coding in Drug Safety: Acquire the basics of coding in Drug Safety, a crucial skill for data management.

16. Case Follow-up Approaches and Handling of Cases: Learn how to handle and follow up on cases efficiently.

17. Clinical Trial Safety Surveillance: Dive into the world of safety surveillance in clinical trials.

18. Phase IV Trials and Pharmacovigilance: Explore the role of Drug Safety in Phase IV trials and post-market surveillance.

19. Case Narratives: Develop the skill to create comprehensive case narratives.

20. SAE Reconciliation: Understand the process of Serious Adverse Event (SAE) reconciliation.

21. Drug Safety Database and Software: Familiarize yourself with the software and databases used in Drug Safety.

22. Special Scenarios: Prepare for special scenarios and challenges that may arise in Drug Safety roles.

ADSA – Advanced Drug Safety Associate Lessons: As you progress in your drug safety journey, the ADSA program offers specialized training in advanced pharmacovigilance practices. Building upon the DSAT foundation, ADSA delves into intricate topics within the field. Through narrated presentations, role-based tasks, and solutions, you’ll deepen your expertise and prepare for leadership roles in adverse event management and drug safety.

1. Introduction to MedDRA: Explore the Medical Dictionary for Regulatory Activities (MedDRA), a crucial tool for coding and classifying adverse events.

2. MedDRA Coding Guidelines – Part 1: Dive into the first part of MedDRA coding guidelines to master the art of accurate coding.

3. MedDRA Coding Guidelines – Part 2: Continue your journey into MedDRA coding with the second part of comprehensive guidelines.

4. MedDRA Coding Guidelines – Part 3: Delve further into MedDRA coding with the third part of detailed guidelines.

5. MedDRA Coding Guidelines – Part 4: Conclude your MedDRA coding mastery with the fourth part of these essential guidelines.

6. AE Causality Assessments: Learn how to assess the causality of adverse events and their relationship to the administered drugs.

7. ICSR Medical Causality Assessment: Explore the intricate process of assessing medical causality in Individual Case Safety Reports (ICSRs).

8. Introduction to Risk Management Plan (RMP): Gain insights into the fundamentals of Risk Management Plans, a critical aspect of drug safety.

9. Introduction to Risk Management Plan (REMS): Understand the key components and significance of Risk Evaluation and Mitigation Strategies (REMS).

10. Argus Safety End-User Training – Module 1: Familiarize yourself with the Argus Safety system, a widely used pharmacovigilance software.

11. Argus Safety End-User Training – Module 2: Continue your training with the second module of Argus Safety, covering advanced features and functionalities.

12. Argus Safety End-User Training – Module 3: Explore the third module of Argus Safety, focusing on data management and reporting capabilities.

13. Argus Safety End-User Training – Module 4: Dive deeper into Argus Safety with the fourth module, concentrating on signal detection and management.

14. Argus Safety End-User Training – Module 5: Conclude your Argus Safety training with the fifth module, emphasizing aggregate reporting and compliance.

15. Product Quality Complaints (PTC / PQC): Understand the management of Product Quality Complaints and their significance in drug safety.

16. Corrective and Preventative Actions (CAPAs): Explore the implementation of Corrective and Preventative Actions to ensure product safety.

17. Overview of Aggregate Reporting (PSUR/ PBRER): Gain an overview of aggregate reporting, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).

18. Overview of Aggregate Reporting – PADER: Focus on the Periodic Adverse Drug Experience Report (PADER) in the context of aggregate reporting.

19. Overview of Aggregate Reporting – PRAC / DSUR: Explore the Pharmacovigilance Risk Assessment Committee (PRAC) and the Development Safety Update Report (DSUR) within aggregate reporting.

DSAP – Drug Safety Associate Projects: Practical experience is a vital aspect of becoming proficient in drug safety. DSAP bridges the gap between theory and real-world application, allowing you to work on projects that mimic the challenges faced by professionals in the field. Guided by experienced mentors, this hands-on experience hones your problem-solving skills and prepares you for the complexities of the pharmaceutical industry. DSAP ensures you are job-ready and well-prepared to apply your knowledge effectively.

1. Medical Record Extraction: This module focuses on the systematic extraction of relevant medical records and patient data. You will learn how to efficiently retrieve and compile medical information for the purpose of adverse event assessment and pharmacovigilance.

2. Adverse Events Case Processing: This course delves into the comprehensive process of handling adverse event cases. You will gain insights into case assessment, data entry, causality assessment, narrative writing, and the regulatory requirements associated with adverse event reporting.

3. CIOMS Line Listing: This curriculum segment covers the creation of CIOMS (Council for International Organizations of Medical Sciences) line listings. You will understand how to format and structure safety data for regulatory reporting and analysis.

4. Case Processing and FDA Reporting for Medical Devices: In this module, you will explore the unique aspects of adverse event case processing and reporting for medical devices. This includes understanding the regulatory framework, data collection, and submission requirements specific to medical device safety.

5. Revision of SOP Quality Control Procedure: This segment focuses on revising Standard Operating Procedures (SOPs) related to quality control in pharmacovigilance. You will learn how to enhance and streamline quality control processes to ensure data accuracy and compliance.

6. SAE Reconciliation: Serious Adverse Event (SAE) reconciliation involves matching and verifying SAE data between different sources. This course will teach you the techniques and best practices for effective SAE reconciliation.

7. PSUR – Periodic Safety Update Reporting: Periodic Safety Update Reports (PSURs) are crucial in pharmacovigilance. This module covers the preparation and submission of PSURs to regulatory authorities, focusing on compliance and data presentation.

8. Triage: Triage involves prioritizing and categorizing adverse event reports based on their urgency and significance. You will learn how to assess and prioritize cases for efficient processing and timely reporting.

9. Data Entry: Data entry is a fundamental skill in pharmacovigilance. This course will provide you with the necessary skills to accurately enter adverse event data into safety databases while adhering to standardized terminology and coding.

10. Signal Detection: Signal detection involves identifying potential safety signals from adverse event data. You will explore data analysis techniques and criteria for recognizing emerging safety concerns.

11. Labeling Edit Check: This module focuses on performing edit checks to ensure labeling compliance with regulatory requirements. You will learn how to verify that product labels accurately reflect safety information.

12. Quality Control Procedure: Quality control procedures are essential for maintaining data accuracy and compliance. You will gain an understanding of how to implement and adhere to quality control protocols.

13. Resolution of Queries of Pending Cases: Handling queries related to pending cases is crucial for maintaining data completeness and integrity. This course will teach you how to effectively resolve inquiries and address missing information.

14. SUSAR – Suspected Unexpected Serious Adverse Reaction: Suspected Unexpected Serious Adverse Reactions (SUSARs) require special attention. This curriculum segment will cover the identification, assessment, and reporting of SUSARs, focusing on compliance and regulatory obligations.

These comprehensive courses equip individuals with the knowledge and skills necessary to excel in Drug Safety roles, ensuring the safety and well-being of patients and compliance with regulatory requirements.
Getting in Touch:

For more information, please call us at +1 905.228.9698 / +1 905.519.0889 (WhatsApp) or email qpdc@qtech-solutions.ca. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.