Program 14: PG Diploma in Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

This module helps the students to find the scope in

• Drug monitoring
• Pharmaceutical preparations - adverse effects
• Adverse drug reaction reporting
• Product surveillance, Postmarketing
• Legislation

 Course Content:

Section – 1 Introduction of Pharmacovigilance

• Overview of Pharmacovigilance
• Standard Terms and Terminology in Pharmacovigilance
• Introduction to Databases
• Importance of Safety monitoring

Section -2 Introduction to adverse drug reactions

• Definitions and classification of ADRs
• Detection and reporting
• Causality assessment
• Severity and seriousness assessment
• Predictability and preventability assessment
• Management of adverse drug reactions

Section – 3 Case Processing

• Global Perspective of Pharmacovigilance
• Single Case Processing
• Case Narrative Writing

Section – 4 Coding in Pharmacovigilance

• WHO adverse reaction terminologies
• MedDRA and Standardised MedDRA queries
• Eudravigilance medicinal product dictionary

Section 5- Tools used in Pharmacovigilance

• Introduction to Argus
• Introduction to Aris G Pharmacovigilance and safety

Section – 6 PV laws and Guideline

• Regulatory Guideline & Laws in PV
• SOPS in PV
• PV Auditing and Inspection
• Regulatory Aspects in PV

Section - 7 Pharmacogenomics of adverse drug reactions

Who should join?

Minimum eligibility criteria for application to the course would be either of the following:

• A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate.
• A postgraduate or graduate with Chemistry as a subject with at least 50% marks in aggregate.
• A postgraduate or graduate in Pharmacy or Pharmaceutical Science
• A postgraduate or graduate in Medicine
• A graduate or equivalent degree/diploma in Nursing

Course Duration: 4 Month

The classes will be held in Biotecnika Bangalore branch/ Online. 

NB : The course duration mentioned above is not applicable if it is taken under any offer or Scheme. or in any combination thereof. The duration of course can increase or decrease based on the teachers speed.

Lab Partner: Azyme labs