Pharmacovigilance vs drug regulatory affairs

Pharmacovigilance v/s  Drug regulatory affairs

What is the difference between Pharmacovigilance and Regulatory affairs ?

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 Drug regulatory affairs ?
It is the connecting link between the pharma industry and drug regulatory authority of india.
It is the department who takes care of all the documentation work and approval process done by Drug regulatory affairs department.

Job role in PV –

1. To record and to report Adverse events.
2. Access and gather all information related to the Adverse effect happening from the Pharmaceutical product.
3. In-depth interview with the patient.
4. To minimize side effect / Adverse events to make drug very safe and effective for the patient use.

Job role in Regulatory affairs –
1. It involves ensuring the safety, efficacy, and quality of drugs.
2. Their proper manufacturing, distribution, and use of drugs.
3. Drug regulatory affairs play a crucial role in protecting public health by establishing standards and guidelines for the development, approval, and post-marketing surveillance of drugs.

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

Designation in Drug regulatory affairs –
1. Regulatory Authority Trainee
2. Drug regulatory authority trainee.
3. Drug regulatory specialist.
4. Drug regulatory consultant.

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

Salary range in Regulatory affairs-
1.8 lakh to 3 LPA for Freshers

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

Companies in Regulatory affairs –

GSK , Merck , Elanco , Cipla , Emcure Pharmaceuticals , Glenmark , Astrazeneca , Hetero , MSN , Aurobindo

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 Drug regulatory affairs –

1. What Is Regulatory Affairs and what are the roles of Regulatory affairs professional ?
2. What is an investigational New Drug Application (IND) and new drug application (NDA) ?
3. What Is A Drug Master File (DMF) ?
4. What Is A Marketing Authorization Application (MAA)?
5. What are the ICH Guidelines to be Referred for Preparation of Registration Dossiers/applications
Of Medicines (with Respect To Format and Contents In Each Module) ?

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