Pharmacovigilance and Career Path in The Pharmaceutical Industry

Pharmacovigilance 

What is Pharmacovigilance (PVG)?

The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for Medicinal Substance) and Vigilia (Latin for to keep watch). Pharmacovigilance primarily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended.

In addition to therapeutic benefits, medicinal products can also have side effects, some of which may be undesirable and / or unexpected like stomach problems by paracetamol and diarrhoea by antibiotics. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.1

 

Scope of Pharmacovigilance

Pharmacovigilance professionals mostly work with the pharmaceutical industry. However, now days there are many other establishments in which these professionals are required:

 

·       Pharmaceutical/Healthcare and Medical Device Companies

·       Contract Research Organizations (CROs)

·      Business/Knowledge Process Outsourcing companies (BPOs/ KPOs)

·       Medical Research Institute

·   Pharmacovigilance Centre like Uppsala Monitoring Center (UMC), Sweden; National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI)  

·       Healthcare Agencies and Institute

 

The scope for medical writers is therefore incredible and rising. This is a profession which one can do either autonomously as a freelancer, or as an employee in any Pharma/ healthcare organization.

Also read: What is Medical Writing and its Career Path? 

Job Titles in Pharmacovigilance

·         Pharmacovigilance Associate

·         Pharmacovigilance Specialist

·         Pharmacovigilance Officer

·         Drug Safety Officer

·         Drug Safety Quality Assurance Officer

·         Clinical Safety Manager

·         Medical Safety Physician

·         Risk Management and Mitigation Specialist

·         Safety Strategic Lead

·       Clinical/Medical Advisor in Pharmacovigilance and Drug Surveillance

·        Medical Dictionary for Regulatory Activities Coder (MedDRA)

·         PV Compliance Reviewer or Auditor

Software Used in Pharmacovigilance

Some software’s used in pharmacovigilance are:

·         Oracle Argus Safety

·         ArisG

·         Oracle Adverse Event Reporting System (AERS)

·         ClinTrace

·         PvNET

·         repClinical

·         PV works

Salary in Pharmacovigilance Field

Position	India	Germany	UK	US
Pharmacovigilance Associate and Senior Pharmacovigilance Associate	₹2.0-5.2 LPA ₹5.0-6.8 LPA	€60,936  per year	£38,893 - £89,521 per year	$72,500 per year
*Salary based search from different job portals

 

Also read: Drug Regulatory Affairs and Career Options

Summary

Pharmacovigilance (PV) is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. The ultimate goal of pharmacovigilance is to accurately characterize and optimize the benefit/risk ratio of a health product throughout its life cycle. There has already been a significant shift in pharmacovigilance due to changes in legislation, therefore further career opportunities are there in the market.

Also read: Career Scope for Pharmacy Professionals

References

1. Pharmacovigilance - World Health Organization (WHO). Accessed from https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance#:~:text=Pharmacovigilance%20is%20the%20science%20and,they%20are%20authorized%20for%20use.

2. Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 1998 May;45(5):427-31.

3. European Medicines Agency. Pharmacovigilance: Overview. Accessed from  https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance-overview.