mega888 apk Drug Safety-Pharmacovigilance - Advanced Topics (ADSA) - Qtech-USA is a Clinical Science training provider as Private Career School offering Job focused training for Clinical Research, Drug Safety, Pharmacovigilance, CDM , Healthcare and SAS Programming

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 the theoretical aspects of the field and exposure to various 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. The student participates in 7 days Post Training Assistance program for Resume preparation.

  • 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.

  • 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
  • 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 :

DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES
  • Manager, Drug Safety and Pharmacovigilance
  • Manager, Drug Safety Science
  • Medical Operations Leader
  • Local Safety Manager (LSM)
  • Drug Safety Physician
  • Team Lead Quality & Safety
  • Therapeutic Area Lead
  • Safety Review Specialist – Literature team
  • Medical Reviewer
  • Medical Safety Manager

Designed by industry experts for students and young professionals. 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.

ADDITIONAL DRUG SAFETY-PHARMACOVIGILANCE
LIST OF TOPICS:

1.  Introduction to MedDRA

2.  MedDRA Coding Guidelines- Part 1

3.  MedDRA Coding Guidelines- Part 2

4.  MedDRA Coding Guidelines- Part 3

5.  MedDRA Coding Guidelines- Part 4

6.  AE Causality assessments

7.  ICSR Medical Causality assessment

8.  Introduction to Risk Management Plan (RMP)

9.  Introduction to Risk Management Plan (REMS)

10.  Argus Safety End-User Training – Module 1

11.  Argus Safety End-User Training – Module 2

12.  Argus Safety End-User Training – Module 3

13.  Argus Safety End-User Training – Module 4

14.  Argus Safety End-User Training – Module 5

15.  Product Quality Complaints (PTC / PQC)

16.  Corrective and Preventative Actions (CAPAs)

17.  Overview of Aggregate Reporting (PSUR/ PBRER)

18.  Overview of Aggregate Reporting – PADER

19.  Overview of Aggregate Reporting – PRAC / DSUR

  • 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 in an Internship program to meet my career goals.

    Latha T. (New Jersey

  • Category:
    Drug Safety
  • Duration:
    04 Weeks
  • Price:
  • Language:
    English