Advanced Drug Safety Associate Certification and Pharmacovigilance Training
Category:
Drug Safety
 
Duration:
9 Weeks / 180 Hours
 
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ADVANCED DRUG SAFETY

Introduction – Advanced Drug Safety

At Qtech-Sol, we are at the forefront of Clinical Science Training, offering specialized programs tailored to individuals aspiring to embark on fulfilling careers as Drug Safety Associates (DSAs) or Drug Safety Coordinators (DSCs). Our programs are thoughtfully curated to provide a comprehensive educational experience, arming you with the essential knowledge and hands-on skills necessary for excelling in these pivotal roles.

In the capacity of 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 :  Advanced Drug Safety
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  ADSA
Experience Level :  Senior Level
Qualification :  Bachelors / Masters
Student Category :  Recently Graduated / Career Changer
Course Material : This course contains and delivers 35 Lessons.
Every lesson encompasses diverse delivery methods, including
  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

ADSA-SIP Delivery – 9 Weeks / 180 Hours (Self-Paced)

Introduction

Our Advanced Drug Safety Associate (ADSA) program is meticulously crafted to provide comprehensive and specialized training in critical aspects of Drug Safety. With a keen focus on advanced topics and hands-on expertise, this program is designed to prepare you for a dynamic career in the field of pharmacovigilance and drug safety management. Here’s an overview of the extensive curriculum covered in the ADSA program:

In the initial modules, you will dive into the world of MedDRA (Medical Dictionary for Regulatory Activities), a fundamental tool for coding and classifying adverse events. The four-part MedDRA Coding Guidelines series will equip you with the skills needed for accurate and consistent coding, a crucial aspect of drug safety assessment. You’ll also explore the art of causality assessments, learning how to evaluate adverse events and their relationship to administered drugs.

The program delves into Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), providing you with insights into these critical components of drug safety. Furthermore, you’ll familiarize yourself with Argus Safety, a widely used pharmacovigilance software, through a five-module training series. These modules cover various aspects of the software, from basic functionalities to advanced features and signal detection management.

You’ll gain a comprehensive understanding of Product Quality Complaints (PTC/PQC) and the implementation of Corrective and Preventative Actions (CAPAs) to ensure product safety. The curriculum also includes an overview of aggregate reporting, including key reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), the Periodic Adverse Drug Experience Report (PADER), and the Development Safety Update Report (DSUR).

Through this program, you’ll develop the expertise and skills required to excel in advanced drug safety roles, contributing to the safety and well-being of patients and ensuring compliance with regulatory requirements in the pharmaceutical industry.

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

“To embark on a fulfilling career as a Drug Safety Associate (DSA), individuals are ideally equipped with a bachelor’s degree in life sciences or a closely related health discipline, such as Pharmacy, Medicine, Nursing, or PharmD. However, it’s worth noting that certain entry-level roles within the realm of clinical research, such as Drug Safety Assistants (DSAs), may necessitate only an associate degree or, in specific instances, a high school diploma.”

At Qtech-Sol, our DSA Program focuses on computer-based roles that leverage clinical data and tools to ensure the safety of patients participating in clinical trials. Therefore, a foundational understanding of essential computer applications like Microsoft Word, Excel, Notepad, and PowerPoint is crucial for success in this field.

The ideal candidate for DSA roles often comes from backgrounds in pharmaceuticals, healthcare, or research centers, including hospitals. Our program places significant emphasis on the core responsibilities carried out by Drug Safety Associates. These professionals are responsible for meticulously monitoring and evaluating adverse events and side effects associated with drugs and medical products. Students in our program gain hands-on experience and exposure to real-world practices and case studies, covering critical aspects such as pharmacovigilance, regulatory compliance, signal detection, risk assessment, and data management. Additionally, students become familiar with Good Pharmacovigilance Practice (GVP) guidelines, International Council for Harmonisation (ICH) standards, and regulatory requirements governing pharmacovigilance.

Upon successful completion of our program, individuals can explore a variety of job titles within the field of drug safety, including but not limited to:

  1. Drug Safety Associate (DSA)
  2. Pharmacovigilance Coordinator
  3. Adverse Event Specialist
  4. Drug Safety Specialist
  5. Regulatory Affairs Associate

Our comprehensive training equips aspiring professionals with the skills and knowledge necessary to excel in the dynamic and critical role of a Drug Safety Associate, ensuring the safety and well-being of patients 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 Advanced Drug Safety Associate (ADSA) program is designed to provide in-depth knowledge and expertise in the critical aspects of Drug Safety. With a focus on advanced topics and specialized training, this program prepares you for a dynamic career in pharmacovigilance and drug safety management. Here is an overview of the comprehensive lessons covered in the ADSA program:

Advanced 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.
Getting in Touch:

For more information, please call us at +1 905.228.9698 / +1 732.207.4564 (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.