PV - Pro Breadcrumb

PV - Pro

Pharmacovigilance Training and Internship

Pharmacovigilance is the pharmacological science relating to the detection, assessment, and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and the pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post- marketing drug surveillance.

This course will provide extensive theoretical & training in Pharmacovigilance. It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportability of the case, the expectedness of the event), Data Entry, Case Processing, Medical coding & Narrative Writing.

Duration

45 days training, conducted on weekdays (Monday to Friday)

Topics Covered

Foundation Modules

  • Introduction: Clinical Trial Domain Overview
  • Concepts in Clinical Pharmacology
  • Introduction to Global Pharmacovigilance
  • Pharmacovigilance Methods

Core Modules

  • Global Pharmacovigilance Regulations: USA, Europe, India, Australia, Japan, Rest of the World
  • Medical Coding
  • Literature Search
  • Individual Case Safety Reports – Part I
  • Expectedness, Causality & Relatedness
  • Safety Narrative Writing
  • Individual Case Safety Reports – Part II
  • Safety Writing – Aggregate Reporting
  • (PSUR, PBRER, DSUR)
  • Signal Detection – Methods & Challenges
  • Risk Management
  • Risk Benefit Assessment
  • Safety Data Exchange Agreements
  • Business Models & Project Management in Pharmacovigilance
  • Special Scenarios in Pharmacovigilance
  • Introduction to Pharmacoepidemiology
  • Safety Database

Batch Size

10 students per batch

Eligibility:

Candidates are preferred from

  • Life Sciences (M.Pharmacy, B.Pharmacy, M.Sc.)
  • MBBS, BDS, BHMS, and BAMS

Features of this course

  • Complete Course Material will be provided including detailed information about the entire work flow of Drug Safety Associate.
  • 2 months internship available after rigorous training in Pharmacovigilance.
  • Simulated real time Projects
  • We Provide Real Time Experience on Pharmacovigilance database, Clinevo*
  • Regular assessments to improve and rank the performance
  • *Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end-to-end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals capabilities under one platform.

Mode of Training

  • Virtual Classroom and Classroom

Mode of Payment

  • Payment can be done by Payment gateway/Online Transfer

PV - Pro internship will commence shortly watch this space for more information!