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.
45 days training, conducted on weekdays (Monday to Friday)
- Introduction: Clinical Trial Domain Overview
- Concepts in Clinical Pharmacology
- Introduction to Global Pharmacovigilance
- Pharmacovigilance Methods
- 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
10 students per batch
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!