Pharmacovigilance Certification and Drug Safety Training
Category:
Drug Safety
 
Duration:
6 Weeks / 40 Days
 
 

DRUG SAFETY PROJECTS (DSA ROLE BASED)

Introduction – Drug Safety Projects (DSA Role Based)

“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 Projects (DSA Role Based)
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  DSAP
Course Material : This course contains and delivers 14 Lessons.
Every lesson encompasses diverse delivery methods, including
  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
  2. Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

DSAP-SIP Delivery – 6 Weeks / 40 Days (Self-Paced)

Introduction

Welcome to Advanced Role-Based Drug Safety Training, where we delve into the multifaceted world of Drug Safety Associates (DSAs) and their advanced roles in pharmacovigilance. DSAs are tasked with responsibilities that encompass signal detection, risk mitigation, regulatory compliance, and data analysis, requiring a deep understanding of pharmaceutical safety. Throughout this program, we will explore complex tasks such as medical review, aggregate reporting, and cross-functional collaboration. Our curriculum covers key areas, from drug safety database management to benefit-risk assessment, ensuring you gain the expertise needed to excel in these vital roles. As the pharmaceutical landscape evolves, DSAs play a crucial role in safeguarding patient well-being and maintaining product integrity.

In our Advanced Drug Safety Training program, we offer a comprehensive curriculum that covers an array of crucial topics, providing you with the expertise required for success in Drug Safety roles. The program begins with a focus on Medical Record Extraction, where you will learn systematic techniques for efficiently extracting relevant medical records and patient data, essential for adverse event assessment and pharmacovigilance.

Next, our Adverse Events Case Processing course delves deep into the intricate process of managing adverse event cases. Here, you’ll gain insights into case assessment, data entry, causality assessment, narrative writing, and the regulatory requirements associated with adverse event reporting. The program also includes specialized modules such as CIOMS Line Listing, Case Processing and FDA Reporting for Medical Devices, and Revision of SOP Quality Control Procedure, each designed to enhance your skills in various aspects of pharmacovigilance and safety data management.

Our curriculum covers everything from SAE reconciliation to PSUR preparation and submission, ensuring you have a comprehensive understanding of the intricacies of drug safety. By the end of these courses, you will be well-prepared to excel in Drug Safety roles, safeguarding patient well-being, and ensuring compliance with stringent regulatory requirements.

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 Data Analyst
  7. Pharmacovigilance Compliance Manager
  8. Signal Detection Scientist
  9. Medical Reviewer
  10. Risk Management Specialist
  11. Pharmacovigilance Auditor
  12. Drug Safety Consultant
  13. Pharmacovigilance Trainer/Educator
  14. Pharmacovigilance Project Manager
  15. Drug Safety Project Coordinator
  16. Pharmacovigilance Systems Analyst
  17. Pharmacovigilance Business Analyst
  18. Clinical Safety Scientist
  19. 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.

Curriculum Overview

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:

Drug Safety Projects (DSA Role Based)
DSAP – Drug Safety Tasks- Projects

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 +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.