Drug regulatory affairs Vs Pharmacvigilance

Hello Everyone,

Hope you all are doing well ,

So lets get start drug regulatory affairs Vs pharmacovigilance

So first we know about the DRA And PV

Q. What is Pharmacovigilance ?

The sciences and activities related to the detection , assessment , understanding and prevention of adverse drug effect and any other possible drug related problems.

Q. What is Drug regulatory affairs ?

Encompasses all aspects of the pharmaceutical development process subject to the regulation ,ensuring the safety ,efficacy and compliance of drug before and after market approval.

Q. What is job profile in Pharmacovigilance ?

Here’s a more detailed breakdown of common job profiles in PV

• Pharmacovigilance officer/associate
• pharmacovigilance manager/Scientist
• risk management specialist
• medical writer
• data analyst/scientist
• clinical research associate

Q. What is job profile in Drug regulatory affairs ?

In that,

• ensuring compliance
• regulatory submission
• post market surveillance
• staying update
• communication and collaboration
• documentation management
• audits and inspection
• policy development
• labeling and packaging

Q . What is the salary for Pharmacovigilance ?

Pharmacovigilance role is around ₹23,845 per month, with an average salary of ₹20,500 per month

Q. What is the Salary For Drug regulatory Affairs ?

the average salary for someone in drug regulatory affairs in India ranges from ₹17.1 lakhs to ₹34.5 lakhs per year, with the top 10% earning more than ₹30.3 lakhs

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.

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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