Pharmacovigilance vs clinical data management

Pharmacovigilance v/s Clinical Data Management

What is the difference between Pharmacovigilance and Clinical Data Management

What is Pharmacovigilance ?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

What is Clinical Data Management ?

Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards.

Designation in Pharmacovigilance –
1. Drug safety Associate
2. Drug safety Trainee
3. Drug safety Specialist

Designation in CDM –
1. Clinical Data Coordinator
2. Clinical Data Reviewer
3. Clinical Data operator
4. Clinical Data Management Trainee

Role of PV –
1. Record and report ADR
2. To connect with patient and healthcare professionals
3. PSUR on drugs and treatment
4. Minimise risk of serious adverse drug event
5. Safety audit

Role of CDM –
1. CRF design
2. Database build and testing
3. Discrepancy management
4. SAS reconciliation
5. Coding

Salary range in PV –
2.5 lakh to 3.5 LPA for Freshers

Salary range in CDM –
2.5 lakh to 3.5 LPA for Freshers

Skills required in PV –
Pharmacology and toxicology
Medical terminologies
Classification and Mechanism of action of Drugs .

Skills required in CDM –
Information on Clinical trials.
Phases of Clinical trails
Drug development process

Companies in PV –
TCS , Wipro , Accenture, Cognizant , Parexel

Companies in CDM –
ICON , PPD , Novartis , Pfizer , Eli Lilly , Medpace

Interview Questions of PV –
1.What is ADR ?
2.What is ADE ?
3.What is Medra Coding ?
4.What do you mean by Narrative writing ?
5.Mechanisms of action of drugs and various classification of drug ?

Interview Questions of CDM –
1.Clinical Trials 4 phases in detail ?
2.What is CRF ?
3.Principles of ICH GCP ?
4.What is 21 CFR Part 11 ?
5.What is SAE reconcillation ?

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One thought on “Pharmacovigilance vs clinical data management”

  1. pharmacovigilance training program May 14, 2024

    “Such a gem of a post!”

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