Pharmacovigilance – Keeping up the Vigil
One sector that would always boom and is recession proof is Healthcare and its cousin, Pharma. With many drugs hitting the market, there is a growing need for vigilance and a check to prevent and monitor the adverse effect of drugs. There is a complete science to it. It is called Pharmacovigilance.
Let us understand what it is and what are the careers in this growing field.
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy.Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Simply put, Pharmacovigilance, is drug safety. It can be defined as the study and prevention of adverse effects caused by pharmaceutical products. Pharmacovigilance is the reason that many drugs are withdrawn from or not even brought into the market at times.The government supports and helps to implement courses in pharmacovigilance as their primary goal is to ensure students of medicine are aware of the adverse effects of certain pharmaceuticals. Pharmacovigilance makes it possible to implement quality systems in all pharmaceutical companies that manufacture large amounts of medicine.
Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder must be submitted to the local drug regulatory authority. Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.
Who are Pharmacovigilance officers?
Pharmacovigilance officers are drug safety officers. They are responsible for monitoring and reporting the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials. They must liaise closely with medical and drug company representatives, patients, doctors, and other healthcare professionals to record the effectiveness of drugs and other treatments. The data is meticulously recorded, analyzed and processed because the informed opinions of pharmacovigilance officers will help pharmaceutical companies maximize product safety and performance, and cut down on adverse effects.
Genesis:
Pharmacovigilance (PV) was officially introduced in December 1961 by an Australian doctor who first suspected a causal link between serious fetal deformities and thalidomide, a drug used during pregnancy: Thalidomide was used as an antiemetic and sedative agent in pregnant women. In 1968, the World Health Organization (WHO) promoted the “Programme for International Drug Monitoring”, a pilot project aimed to centralize world data on adverse drug reactions (ADRs). In particular, the main aim of the “WHO Programme” was to identify the earliest possible PV signals.
Career scape:
Pharmacovigilance is a great career option for life science and pharmacy graduates. It is a scientific discipline that is primarily concerned with reporting and analyzing of drug side effects. It is primarily due to the work of Pharmacovigilance professionals that the drugs in the market that we consume are mostly safe and those that are found harmful are taken off the market. Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market. After a drug side effect is reported, the Pharmacovigilance professionals enter the event in relevant databases, follow up with the case to gather more information and forward these reports to regulatory authorities and other applicable bodies. The Pharmacovigilance professionals identify signals in data that may point towards a potential side effect and probe the case further.
Job responsibilities:
- recording and reporting adverse reactions received from healthcare professionals and consumers
- conducting in-depth interviews with patients and healthcare professionals
- developing a thorough knowledge of products
- completing periodic safety update reports on drugs and other treatments
- writing and reviewing serious adverse effects reports and forms
- flagging up early warning signs of adverse effects of drugs
- minimizing the risk of serious side effects
- completing safety audits
- working on clinical trials of new drugs
Getting in :
Candidates of pharmacovigilance can pursue both certificate and diploma courses.In order to pursue a career in pharmacovigilance, the minimum eligibility criteria to apply for the course is:
- A postgraduate or graduate degree in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate
- A postgraduate or graduate degree with Chemistry as a subject with at least 50% marks in aggregate
- A postgraduate or graduate degree in Pharmacy or Pharmaceutical Sciences
- A postgraduate or graduate degree in Medicine
Institute scape:
- Institute of Clinical Research, India, postgraduate diploma in Pharmacovigilance.
- Clinical Research Institution and Management Academy, CREMA, Mumbai, and Bangalore offering postgraduate diploma in Pharmacovigilance.
- Apeejay Stya University, Gurgaon, Certificate in Drug Regulatory Affairs.
- Innovative center for BioSciences Clinical Research, Mohali,postgraduate diploma in Pharmacovigilance.
Career Pathways:
Till a few years ago, B.Sc and M.Sc graduates were hired for Pharmacovigilance. Soon companies started getting B.Pharm people in the same pay scale as B.Sc n M.Sc. hence companies started hiring Pharmacy graduated and postgraduates. You can make a career in creating, Individual Case safety reports(ICSR’s), PSUR Periodic Safety update reports, Signal detection, Risk Management, Medical Coding, and Medical Writing.
An entry-level job in Pharmacovigilance is DSA (Drug Safety Associate). DSAs are mainly involved in case creation, checking for MSI (Minimum safety information – a patient, a reporter, a suspect drug and an adverse event), reconciliation and followup process, data entry of all information available in the document and medical coding. Once a candidate has 2-3 Years experience and builds required skill sets (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance) he can go on to become a DSS (Drug Safety Scientist).
Top recruiters:
You can find good job options in the following sectors:
- Pharmaceutical Companies (MNCs & Indian) & Biotech companies.
- Clinical Research Organizations.
- Regulatory Agencies like DCG (I) & CDSCO
- Pharmacovigilance units in Medical colleges & Hospitals
Asian clinical trials serene, Bioserve, Clin invent, Clintec international, Clinigene, Dr Reddy’s lab, Elly Lilly, Glaxo SmithKline, IGATE clinical research, Johnson & Johnson, Lambda therapeutic research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, Siro Clinpharma, Synchron, Sanofi Aventis, Torrent Pharma, Reliance life science, Amed, Accutest, Actimus, Adroit insights, Alembic, Asian Clinical Trials.
The Road Ahead:
The career in Pharmacovigilance is quite bright. At present, India is the fourth largest producer of pharmaceuticals in the world and therefore is a surfeit of drug brands with more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. India offers unique advantages for the growth of Pharmacovigilance that include rapid induction of New Chemical Entities (NCEs) and high technology pharmaceutical products in the market, an abundance of patients with genetic diversity, presence of Lakhs of formulation in the domestic market and a large world-scale Adverse Drug Reaction (ADR) database.
All this makes India an escalating platform for an exciting and lucrative career in Pharmacovigilance.
