Introduction to Pharmacovigilance
Pharmacovigilance is the science concerned with the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related problems. Its main role is to ensure that medicines remain safe when they are used by the general population, not just during clinical trials.
Clinical trials involve a limited number of patients under controlled conditions. Once a drug is marketed, it is used by people of different ages, diseases, and genetic backgrounds. Pharmacovigilance monitors drug safety in these real-world conditions and identifies risks that may not appear during trials.
Origin and Need
The word pharmacovigilance is derived from pharmakon (drug) and vigilantia (watchfulness), meaning careful monitoring of medicines. The need for pharmacovigilance became evident after the thalidomide tragedy in the 1960s, where the drug caused severe birth defects. This incident highlighted that drug safety must be continuously monitored even after approval.
Purpose of Pharmacovigilance
The primary purpose of pharmacovigilance is protection of public health. It helps identify unknown adverse effects, assess risk–benefit balance, and prevent harm to patients. Based on pharmacovigilance data, regulatory authorities may update drug labels, restrict use, issue warnings, or withdraw unsafe medicines from the market.
Pharmacovigilance Process
The process begins with reporting of adverse drug reactions by healthcare professionals, hospitals, pharmaceutical companies, or patients. These reports are analyzed to evaluate seriousness, causality, and patterns. If a safety signal is detected, further investigation is carried out and appropriate regulatory action is taken.
Regulatory Framework
In India, drug safety monitoring is managed through the Pharmacovigilance Programme of India (PvPI). At the global level, organizations such as the WHO, US FDA, and EMA regulate pharmacovigilance activities. Pharmaceutical companies are legally required to submit safety reports like PSURs and maintain risk management systems.
Career Scope in Pharmacovigilance
Pharmacovigilance offers strong career scope due to strict regulatory requirements and growth of the pharmaceutical and CRO industry. Common roles include Drug Safety Associate, Pharmacovigilance Officer, Medical Reviewer, Signal Detection Analyst, and Aggregate Report Writer. With experience, professionals can move into managerial or regulatory roles.
Companies Hiring Pharmacovigilance Professionals
In India, pharmacovigilance hiring is mainly done by CROs, pharma MNCs, and IT–life science companies.
Major recruiters include IQVIA, Cognizant, Accenture, TCS Life Sciences, Wipro, Capgemini, and HCL. These companies handle global drug safety work for US and European pharmaceutical firms.
Leading CROs hiring for pharmacovigilance roles are Parexel, ICON, Syneos Health, PPD, Labcorp (Covance), and Medpace. Most freshers start here in case processing roles.
Large pharmaceutical companies such as Pfizer, Novartis, Roche, Sanofi, GSK, AstraZeneca, and Johnson & Johnson have pharmacovigilance teams, but entry-level openings are limited and competitive.
Indian pharma companies like Sun Pharma, Dr. Reddy’s, Cipla, Lupin, Zydus, and Aurobindo also recruit pharmacovigilance professionals for regulatory and post-marketing safety work.
Salary in India
Freshers usually start as Drug Safety Associates with salaries around ₹15,000–₹20,000 per month. With experience, pharmacovigilance officers earn ₹30,000–₹50,000 per month. Senior professionals such as medical reviewers, signal detection experts, and PV managers can earn ₹1,00,000 or more per month, especially in multinational companies and CROs.
Bottom Line
Pharmacovigilance is a serious drug safety discipline, not just a desk job. It requires medical knowledge, attention to detail, and regulatory understanding. For pharmacy and life-science graduates, it offers stable growth, global relevance, and long-term career security.
Read about scope, career opportunities and salaries in Medical coding.