Pharmacovigilance

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Technology

Overview

Curriculum

Features

Overview

Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. This course provides an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies and medical devices), with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem.

Curriculum

Why to take this course:

Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary
Outline how drug safety / pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies.
Sketch how a product safety database is compiled, how a product’s safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers.
Apply appropriate terms to describe different types of adverse effect.
Specify requirements to report adverse reactions to regulators.

Course curriculum:

Drug discovery process
Phases of clinical trials
Good clinical practice
Scope and process flow of Pharmacovigilance
Pharmacovigilance glossary
Safety databases
Types of cases
Case Assessment which includes
Duplicate check
Check the validity of case
Seriousness
Medical coding using MedDRA, CDD and WHODD
Causality and Listedness assessment
Narrative writing
Regulations and timelines Introduction to Medical Writing
Introduction to Data Management
Preparation of CV
Mock interview

Required Educational Qualifications in under graduation:

B.Pharmacy, Nursing, MBBS, Physiotherapy, BDS (dentist), Homeopathy/Ayurvedic, Biochemistry, Biotechnology, Microbiology, B.Sc biology/Zoology and any Para-medical and life sciences background.

Educational qualification in USA (M.S):

All healthcare related fields (Parma, nursing, healthcare management, public health etc), Chemistry, Regulatory Affairs, All Management fields and Information systems/Information Technology (I.T) with any of the above under graduation can apply for this position.

Target industries:

All the pharmaceutical companies, CROs (clinical research organizations), BPO/KPO (like Accenture, Cognizant, TCS etc).

Target Positions:

Drug Safety Associate, Pharmacovizilance Associate, Drug Safety Co-coordinator, Sr. Drug Safety associate, Pharmacovigilance specialist, Pharmacovizilance Scientist, Case processing associate/specialist etc.

Course structure:

Total hours of training: 20-25 hours

Duration of training: less than 2 weeks

Material: Well prepared material which includes PPTs and PDFs and Database documents will be provided.

Resume Preparation: Resume preparation will be done once the candidate completes the training

Key concepts of the Course: Adverse events, Medical coding, Product coding, MedDRA, WHO-DD, CDD, Narrative writing, Argus database, ARISg database, ICSRs (individual case safety report), Aggregate reporting, PSURs/DSURs, Suspect drugs, concomitant medications, De-challenge, Re-challenge, Investigations, SAE reconciliation etc.