Advanced Drug Safety Associate (ADSA)

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Advanced Drug Safety Associate (ADSA)

3 Students Enrolled

The process of drug development is generally divided into 2 stages: (1) New lead discovery (Preclinical Research) and (2) New product development (Clinical Development). Drug Safety – Pharmacovigilance Associate can work in Pharmaceuticals, Medical Device, Hospitals and research institutions, such as academic health government agencies and departments, contract research organizations/ centers. Their primary role is to identify safety and risk information, evaluate and report with regulatory authorities. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

Our Programs are delivered in 2 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation.

Category: Drug Safety Lessons: 14 Lessons Duration: 04 Weeks / 120 Hours Language: English
Admission Requirements:

Recommended: A Bachelor or Master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry.

Institutional Scholarship / Promotion:

Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources qpdc@qtech-solutions.ca to check on your eligibility. We will contact you. Qtech's objective is to provide you the right career pathway and advancement required to meet your career goals.

Learning Outcomes:

The Benefit Student Gains

  1. Upgrading the Knowledge required.
  2. Better Resume Placement for promising jobs.
  3. Low Investment, high learnings
  4. Learn from Anywhere, Anytime at your pace.
  5. Job and Title Based Tasks as followed and Practiced in industry
  6. Applying Concept into Real-time (Policies, governance and tools)
  7. Work on Role Based Tasks followed and Practiced in industry
  8. Mocks and Narratives for Client Discussions
  9. Readiness to work with limited support
Career Pathways

Our objective is to help students to meet the following career pathways. Typical Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are :

SENIOR DRUG SAFETY / PHARMACOVIGILANCE JOB TITLES
Senior Drug Safety / Pharmacovigilance Associate Occupational Health & Safety Specialist Senior
Operations Specialist, Drug Safety Vendor Case Management Specialist
Pharmacovigilance Scientist Quality Safety Manager
Drug Safety Specialist Patient Safety Data Manager
Medical Safety Assessment Physician Drug Safety Scientist
Case Medical Evaluator Global Drug Safety Specialist
  • Curriculum Overview:

    The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Quality Assurance concepts towards Drug Safety in reference to roles and responsibilities performed by Drug Safety / Pharmacovigilance Associate. Core topics includes Role of DSA (Trials), Clinical Trial Safety Surveillance, Phase IV Trials and Pharmacovigilance, Introduction to Adverse Events, SAE Reconciliation, Characteristics of a Case, Sources of Individual Case Reports, Basics of Coding in Drug Safety, Case Narratives, Medical Review, Case Follow-up Approaches and Handling of Cases, MedDRA and Argus reporting, Drug Safety Data Extraction and Pre-processing. The course curriculum is designed to give an edge to obtain job opportunity in Drug Safety / Pharmacovigilance field.

    ADVANCED DRUG SAFETY ASSOCIATE

    LIST OF TOPICS

    The real time scenario case is assigned to each topic:

    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

    What is the Difference Between
    DSA and Advanced DSA Training?

    DSA

    Basic and core topics and exercises

    Certain educational background is strongly recommended to enter the industry

    Designed for non-experienced individuals to enter into field

    In depth knowledge of roles and responsibilities of DSA + theoretical aspect with projects which help to understand industry requirements

    ADSA

    Advancedtopics and exercises

    Prior training or relevant experience is required

    Designed for experienced professionals to add new skills set

    Exposure to diverse DSA exercises, real time documentation + advanced learning supported by practical case scenario tasks and follow up process

     

Instructor

qtech-admin

5.00 average based on 3 ratings

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Reviews

  • "I am very thankful to Qtech learning center team for providing training in advanced Drug Safety program (ADSA), as it will be helpful for me to gain experience in real time.

    Maureen D

    Mallika P

  • The training helped me enhance my skills. The training was given in a very well planned, organized and professional manner.

    Gamal

    Neepa Y

  • With Qtech-Sol, I learned what is Drug Safety for pharma drug development, handling and regulations. This program gave me a foundation for further pursuing drug safety job. Thank you very much

    Sangeetha

    Lily W