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Pharmacovigilance Oracle Argus Safety Database 7.0

Certificate

In Chandigarh ()

₹ 40,000 VAT incl.

Description

  • Type

    Certificate

  • Duration

    2 Months

  • Internship

    Yes

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

About this course

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

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Subjects

  • Pharmacovigilance
  • ARGUS
  • Clinical Data Management
  • SAS EIS Software
  • Oracle Certification

Teachers and trainers (1)

Sunil Verma

Sunil Verma

Director – Pharmacovigilance Training (Corporate Services)

Mr. Sunil Verma is the Founder & CEO of ACI, a reputed and fastest growing Pharmacovigilance Training Management Company with national and international presence. ACI delivers Pharmacovigilance Professional Training Programs for fresher and also has strong base in corporate training services across emerging markets. ACI is rated amongst the top training company globally for its quality systems and compliance. For the last 5 years, Mr. Sunil has focused on delivering high quality training service to fresher, Pharmaceutical and CROs in Pharmacovigilance.

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

Pharmacovigilance Oracle Argus Safety Database 7.0

₹ 40,000 VAT incl.