Pharmacovigilance Certification and Drug Safety Training
Category:
Drug Safety
 
Duration:
6 Weeks / 40 Days
 
DSAP BROCHURE
 
DSAP COURSE DEMO
Enroll and Tuition
 
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Qtech-Sol DSA Projects Course

Clinical Trials Projects

Qtech-Sol DSA Projects Course.

Course Name :  Drug Safety Projects
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  DSAP
Course Material : This course contains and delivers 14 Lessons.
This DSAP Course contains lessons with various delivery modes as presentation and Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Course Demo : Register for COURSE DEMO
Fill out Registration form and select module name Clinical Sciences and select course “Drug Safety Associate”.
You will receive an email with weblink to self-activate your demo course.
Upon activation will have access to 4 lessons for next 5 days.
Online Discussion : Book your slot for a personalized ONE-O-ONE discussion with us. You will receive an online invite to participate via email.
To complete your enrollment, please email your resume to qpdc@qtech-solutions.com
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

DSAP-SIP Delivery – 6 Weeks / 150 Hours / 40 Days (Self-Paced)

Introduction

This course provides projects and hypothetical tasks as learning to work as DSA or Pharmacovigilance Associate. This is a job and title focused program focusing on Drug Safety and Pharmacovigilance tasks performed during Clinical Trial and Long-Term Phase IV (Post-Marketing Surveillance) studies. This is a job and title focused program. The course emphasizes about Case Registry, Triage, Argus Data Entry (Case Studies, ICSR), QA/QC , Medical Review and Submissions of E2B Safety data with regulatory authorities. The course curriculum is designed to give an edge to obtain job opportunities in the drug safety field with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Start to Finish Steps:
  1. Submit Online Application
  2. Pay applicable tuition (Shopping cart)
  3. Email credentials required
  4. Receive Course Activation email
  5. Obtain access to Course and Solution bank (LMS)
  6. Receive support for subject related queries.
  7. Submit Course task deliveries per schedule shared
  8. Take Final exam upon completing he course
  9. Obtain Course completion certificate and transcript
  10. Get Started with PTA program for next steps
Gaining experience

This program includes theoretical and Practicum concepts as case studies related to Role of DSA, Introduction to Adverse events, Basics of Coding in Drug Safety. Argus Medical Record Extraction, Triage, Characteristics of a Case, Case Processing, Argus Data Entry, Case Narratives, Drug safety Database and Software, CIOMS Line Listing, Signal Detection, Drug Labeling and Edit Checks, Quality Control Procedures, SAE Reconciliation, Resolution of Queries for Pending Cases, PSUR Reporting and SUSAR.

Being a significant part of the pharmacovigilance and safety services (PVSS) department, a Drug Safety Associate (DSA) is a key job profile for drug safety management in clinical trials and post marketing surveillance (PMS). Once a drug has been marketed the work for a DSA begins after. As soon as an alert of a serious adverse event (SAE) is raised the clock starts and sets into motion the necessary tasks that need to be completed to process the events.

Examples of job titles to apply
  1. Drug Safety Associate
  2. Drug Safety Assistant
  3. Pharmacovigilance Associate
  4. AE Case Processor
  5. Medical Record Extractor
  6. Patient Safety Coordinator
  7. Triage Processor
  8. E2B Case Reporting and Submission

  • Eligible Education:

    Recommended:A Bachelor or Master’s degree in Medicine, Nursing (RN), Doctorate in Pharmacy (PharmD), Public Health, Pharmacy, Pharmaceutical or Industrial Chemistry.

    Resume Marketing Services

    Your resume is front face to hiring recruiters and organizations to pre-screen or call for an interview. With competition out in market, does your resume meet the requirements. Contact us to participate in our Resume Marketing Services (RMS) program for resume build, interview narratives, and mock. It is as well important to know, the current hiring organizations in your area, open positions available, salary range, fitness of resume to apply and many more. During this PTA program you will have opportunity to discuss with our course specialist to learn and discover opportunities in small steps. We shall work together as team to achieve this goal.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support
  • Professional organizations

    Professional organizations and associations are membership-based groups comprised of people working in a similar field. They can be helpful resources for students to learn more about a field, develop connections and discover related opportunities.

    Check out World-Wide Clinical Resource Information. Follow the resource links to learn what’s happening around the world on current news and updates about Clinical trials, Regulatory, CDM and Pharmacovigilance.

    Reviews

    Qtech-Sol has trained since 2000, many candidates with different education background and skills. Few of them are currently working as directors in top MNC companies.

    The program gave me an in-depth understanding of the role of a DSA in the Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    – Ramya I (New Jersey)

    The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    – Kinjal C (Virginia)

    I am a Medical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Drug Safety Associate training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled into an Internship program to meet my career goals.

    – Latha T. (New Jersey)

    Getting Connected

    For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

Curriculum Overview

This course is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The training provides in role-based tasks as exercises with solutions to perform as Drug Safety Associate / Coordinator (or) Pharmacovigilance Specialist. The curriculum includes theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements.

Drug Safety Projects
DSAP – Drug Safety Tasks- Projects

1. Medical Record Extraction

2. Adverse Events Case Processing

3. CIOMS Line Listing

4. Case processing and FDA Reporting for Medical Devices

5. Revision of SOP Quality Control Procedure

6. SAE Reconciliation

7. PSUR – Periodic Safety Update Reporting

8. Triage

9. Data Entry

10. Signal Detection

11. Labeling Edit check

12. Quality Control Procedure

13. Resolution of queries of pending cases

14. SUSAR – Suspected Unexpected Serious Adverse Reaction
Getting Connected

For additional information please call us on 732.770.4100 or ENQUIRE. One of our course specialists will contact you at earliest possible.

  • The program gave me an in-depth understanding of the role of a DSA in the Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals, I gained a clear understanding of the practical applications needed for work. Very good course work!

    Ramya I (New Jersey)

  • The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real-time for me.

    Kinjal C (Virginia)

  • I am a Medical Science graduate. This Certificate training helped me to understand the Job-related work process better. The Drug Safety Associate training program offered at Qtech is very useful for beginners, I liked it and highly recommend others. Currently, I am enrolled into an Internship program to meet my career goals.

    Latha T. (New Jersey)