What is Pharamcovigilance

-

 



Pharmacovigilance is the science of detecting, assessing, understanding, and preventing side effects or problems caused by medicines.

In simple words, PV means monitoring the safety of medicines after they are used by patients.


Definition

According to the World Health Organization (WHO):

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.


What is Adverse Drug Reaction (ADR)

An Adverse Drug Reaction (ADR) is a harmful or unwanted effect caused by a medicine.

Example:

Medicine                may causeSide Effect
Antibiotic     sometimes results in    Rash
Painkiller                  may cause    Stomach pain
Chemotherapy drug  results in       Hair loss



If doctors or patients report these reactions, PV teams analyse the data and check if the drug is safe.


What Pharmacovigilance Professionals Do


People working in PV usually:

  1. Collect adverse event reports

  2. Analyze drug safety data

  3. Write safety reports

  4. Submit reports to regulatory authorities

  5. Monitor drug risks

Example workflow:

Patient → Doctor reports side effect → PV team reviews → Report submitted to regulatory authority.


Why Pharmacovigilance Is Important

Pharmacovigilance helps to:

  • Detect new side effects

  • Improve drug safety

  • Protect patients

  • Support safe use of medicines

  • Sometimes even remove dangerous drugs from the market

Example

A patient takes a medicine and experiences:

  • Severe headache, Vomiting

The doctor reports this to the pharmacovigilance system.
PV experts analyse whether the medicine caused the reaction.

If many patients report the same issue, regulators like the
Food and Drug Administration (FDA) or
European Medicines Agency (EMA) may update the drug’s safety warning.


 What a Pharmacovigilance Associate Does (Daily Work)





  1. Receive adverse event reports

    • From doctors

    • Hospitals

    • Patients

    • Clinical trials

  2. Check the report

    • Patient details

    • Drug taken

    • Reaction observed

  3. Enter data into safety databases

    • Common system: Oracle Argus Safety

  4. Medical coding

    • Using MedDRA terminology.

  5. Write case narrative

  6. Submit safety report to authorities

    • Food and Drug Administration

    • European Medicines Agency



TIP:

Focus on these topics 

Basic concepts

  • Adverse Event (AE)

  • Adverse Drug Reaction (ADR)

  • Serious vs Non-serious events

  • Expected vs unexpected events Case processing

    ICSR = Individual Case Safety Report

    ICSR contains:

    • Patient information

    • Drug name

    • Reaction details

    • Outcome

    Medical coding

  • Using MedDRA to code symptoms.

PV Databases Used in Companies

You should know these names:

  • Oracle Argus Safety

  • ARISg Pharmacovigilance System

  • Veeva Safety

Most companies train employees on these tools.


Next module we will learn about the case studies and real work scenarios how PV managed.





    

Comments

Post a Comment

Popular posts from this blog

Dreams of being Graduate to Career goals.

-
 Hi Everyone, I am a B Pharm Graduate from 2017-2021 batch, Let's just see why we want Education as our stepping stone.  Everyone has dreams when they start their education. As students, we imagine a future where our hard work leads to success, stability, and a meaningful career. However, the journey from college to professional life is not always easy. It is filled with challenges, doubts, and moments that test our patience and determination. When I started my education in pharmacy, I had dreams of building a career in the healthcare field. Pharmacy is a discipline that requires dedication, focus, and continuous learning. Like many students, I faced academic pressure, difficult subjects, and the responsibility of preparing for a future that sometimes felt uncertain. Education is not only about passing exams or getting a degree. It is about learning discipline, developing resilience, and understanding how to overcome difficulties. During college, there were times when studies ...
Read more

What Motivated Me to Start This Blog – My Journey After Pharmacy

-
 Every journey has moments of hope, struggle, and learning. My motivation to start this blog comes from my personal experiences after completing my pharmacy education. My journey began with four years of studying pharmacy. Like many students, I had dreams of building a successful career in the healthcare field. Pharmacy education requires dedication, discipline, and continuous effort. However, during my academic years, the COVID-19 pandemic affected many students and their career opportunities. The pandemic disrupted education, internships, and job opportunities for many pharmacy graduates, including me. After graduating, the biggest question in my mind was: What next? I started searching for jobs related to pharmacy. I attended several interviews and spent many hours waiting for opportunities. Despite my efforts, finding the right role was not easy. I also tried to continue my education by attempting higher studies, hoping it would open new career paths. Unfortunately, things did ...
Read more

Upskilling or Upselling? The Truth About Certification Courses for Pharmacy Graduates

-
 Many students and professional struggle to find jobs or excel in their roles. During this period, course providers often promote certification programs promising high-paying jobs in areas like clinical research, data analysis, or drug safety. These programs claim to make students “industry-ready.” However, many graduates later realize that the reality is different from what was promised. Why Many Graduates Choose Certification Courses Due to limited job opportunities, graduates often feel pressured to improve their skills. Certification programs appear to offer: Quick career transformation Industry-recognized certifications Placement assistance High salary promises Because of this, many students invest their time and money hoping it will help them secure better jobs. The Problem with Some Training Institutes While some training programs are genuinely helpful, others focus more on selling courses than helping students build real careers. Common issues reported...
Read more