Pharmacovigilance Trainings

JOB LEVEL: Pharmacovigilance Associates/Drug Safety Associates/Pharmacovigilance Scientists
INTRODUCTION:
Academy of Clinical Intelligence in collaboration with HAROM Solutions introducing Level 1 technical training program on Pharmacovigilance Quality Case Processing . The program include two months of training and one month of internship on live projects by HAROM Solutions for candidates successfully completed the training.
This training program incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance career.
TRAINING RECOGNIATION & ACCEPTANCE:
WHO Pharmacovigilance Guidelines
International Conference on Harmonization
Good Pharmacovigilance Practices Modules
TAKE AWAYS:
Training completion certificate
Internship Experience Letter
Recommendation letter for candidates with good performance in Internship
Opportunity to get hired in HAROM Solutions

DURATION:
TECHNCIAL TRAINING: 8 weeks (Total of 80 hrs)
INTERNSHIP: 4 weeks
TRAINING CONTENT
WEEK 1 THE THEORY AND PRACTICE OF PHARMACOVIGILANCE:
Sessions: Drug Development Process, Introduction to Pharmacovigilance, Pharmacovigilance Terminologies
Practice: Cases to differentiate AE/ADRs, Serious/Non-Serious, Valid/Non-Valid
WEEK 2 CASE PROCESSING IN PHARMACOVIGILANCE
Sessions: Introduction to ADRs - Spontaneous adverse reaction reporting, developing an ADR reporting culture - methods, design, medical content and the importance of reporting, Effective communication in PV, Case Triage and Follow ups, Causality assessment
Practice: Cases to perform triage, Causality assessment
WEEK 3 REPORTING IN PHARMACOVIGILANCE
Sessions: Training on Narrative writing, Expedited Reporting, PSUR/DSURs, Signal Management
Practice: Cases to perform narrative writings
WEEK 4 - REGULATORY ASPECTS OF PV
Sessions: Regulatory guidelines ICH, GVP, 21CFR, Schedule Y and CIOMS
Practice: Cases for complete processing
WEEK 5 PHARMACOVIGILANCE CASE PROCESSING ON DRUG SAFETY DATABASE
Sessions: Introduction to safety databases, Hands on sessions on recording ICSRs, ICSR-Assessment, Data entry and retrieval from ICSR databases, Duplicacy check, Case Bookin
Practice: Cases to perform complete case entries
WEEK 6 MedDRA Coding
Sessions: MedDRA Introduction, Coding guidelines, Practical situations for MedDRA coding
Practice: Cases for MedDRA coding
WEEK 7 -8 PRACTICE ON REAL TIME CASES
Pregnancy Cases
Death Cases
Exception scenarios related to cases
Medication Error, Overdose, Misuse cases
WEEK 9-12 INTERNSHIP with HAROM Solutions
The opportunity to work in close relationship with a drug safety project team, on actual cases with real time case processing, in a cross-functional, multi-cultural and professional environment.



FAQs

Where can I contact the organiser with any questions?

Regarding any training related or payment related query, please contact at 0172-4010894/09988756469 or [email protected]

SCO 117-118, First Floor
Sector 17B, Madhya Marg
Chandigarh-160017
Phone: 0172-4010894, 9988756469