Pharmacovigilance Oracle Argus Safety Database 7.0

Academy of Clinical Intelligence (ACI)
In Chandigarh

Rs 40,000
You can also call the Study Centre
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Important information

  • Certificate
  • Chandigarh
  • Duration:
    2 Months
  • When:
    Flexible
  • Internship
Description

Our short term certification courses help students to be job ready in shorter span of time.

Course highlights:
Job oriented practical training on Pharmacovigilance
Practical hand on exposure to Oracle Argus safety 7.0
Internationally recognized Certification
100% placement assistance
Post training support

Important information
Venues

Where and when

Starts Location
Flexible
Chandigarh
Punjab, India
See map

Frequent Asked Questions

· Requirements

MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical

What you'll learn on the course

Pharmacovigilance
ARGUS
Clinical Data Management
SAS EIS Software
Oracle Certification

Teachers and trainers (1)

Sunil Verma
Sunil Verma
Expert in Pharmacovigilance processs

Providing Training Services in Clinical Operations, Clinical Data Management (Oracle Clinical & Oracle Inform Central Designer), Pharmacovigilance (Oracle Argus Safety Database & Oracle AERS), and SAS (Basics & Clinical) 7+ Years experience in Clinical Research Expertise in Clinical Data Management, Pharmacovigilance & SAS 4+ Years training experience

Course programme

The focus of the lectures is mainly on:

  • History and over view of pharmacovigilance
  • Introduction and responsibilities: USFDA, EMA and CDSCO
  • Pharmacovigilance in India
  • Clinical Development process
  • Different phases of clinical Trials
  • Adverse events and its types
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse events reporting
  • Different types of AE reporting Forms
  • Expedited reporting and its timelines
  • Different departments working on Pharmacovigilance
  • Roles and responsibilities of case receipt unit
  • Roles and responsibilities of Triage unit
  • Four factors for the reportable case
  • Seriousness criteria of adverse event
  • Expectedness or Listedness of adverse event
  • Causality assessment of the adverse event
  • Introduction to safety databases and different types
  • Importance and procedure of duplicate check
  • Case bookin or initiation
  • Introduction to MedDRA and WHODD
  • Narrative writing
  • Case quality check, Medical review and its submission.
  • The Qualified Person for Pharmacovigilance (QPPV)
  • PSUR and its submission timelines.

Practical Training will be also provided on Oracle Argus Safety Database on the following topics:

Case processing

MeDRA coding & WHO DD coding

Duplicate Check and case initiation

SAE Narrative writing

Additional information

Our Certification Program in Clinical Data Management & Pharmacovigilance will help you in the following ways: Entry in the groups of highly demanding Professionals in the field of Clinical Research  & Pharmacovigilance Get a good salary package at the entry level Get a good career shifts for working professionals Give an “extra edge” to your resume

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