pharmacovigilance course online

22/09/2015 Other Classes

Price: Free


Pharmacovigilance Training in Oracle Argus Safety Database with Project

BioMed Informatics Medwin Hospitals

(Established in the year of 2000)

BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering trainings since the year of 2000 that are helpful for Pharmacy/Life Sciences students to enter into IT Companies and Pharma, Biotech, CRO industries.

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.


Online Training Features:

  • Web based classroom

  • One faculty/student

  • Placement support

  • Regular/Fast track/Weekend batches

  • Flexible timings 

  • Training Mode: Skype/Teamviewer

  • Hands-On Training on the Database

  • Direct access to Oracle Argus Safety Database

Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…

Certification Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.

Interested candidates are kindly requested to fill the enquiry form in the website for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents. 


G.V.L.P. Subba Rao

BioMed Informatics (Established in the year of 2000)

Medwin Hospitals B Block First Floor,

Nampally, Hyderabad-500 001, India

Phone: 040 - 40209750


Course Curriculum:

  • Clinical Development process

  • Different phases of Clinical Trials

  • History and overview of Pharmacovigilance

  • Introduction and responsibilities of USFDA, EMA and CDSCO

  • Pharmacovigilance in India

  • 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

  • Importance and procedure of duplicate check

  • Data Entry

  • Case booking or initiation

  • Case processing

  • MedDRA and WHODD coding

  • SAE narrative writing

  • Case quality check, Medical review and its submission

  • PSUR and its submission timelines

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