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Pharmacovigilance Training and Internship

The Whiteboard Academy offers detailed & practical Pharmacovigilance course with internship support. There is a demand of Pharmacovigilance trainees and associates in the industry who can perform literature search and preparation of clinical overview on timely manner in sync with companies situated worldwide. The Whiteboard staffing team helps aspirants to get suitable placement in the companies. For more information on openings related to pharmacovigilance connect with the counselor.

What is Pharmacovigilance?

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.

Pharmacovigilance training contains 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, report-ability of the case, the expectedness of the event), Data Entry, Case Processing, Medical coding & Narrative Writing.

Duration

3 Months

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
  • Pharm D

Features of this course

Our Knowledge partner: Oviya MedSafe is a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in India in 2012 and in the United Kingdom in 2014, offering advisory and outsourced support to the pharmaceutical industry. Oviya MedSafe works with renowned pharmaceutical companies and marketing authorization holders in various parts of the world.

  • Access to course material including detailed information about the entire work flow of Drug Safety Associate.
  • Internship and industry exposure after rigorous training in Pharmacovigilance.
  • Access to Safety Database during internship. 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
  • Work on simulated real time projects
  • Regular assessments to improve and rank the performance
  • Work as project intern with Oviya MedSafe global CRO
  • Get experience letter
  • Placement Assistance

Mode of Training

  • Virtual Classroom and Classroom

Mode of Payment

  • Payment can be done by Payment gateway / Online Transfer