Market Research

Pharmacovigilance Outsourcing and Career Advantages for Indian Professionals

Pharmacovigilance is an extremely important element in the development, trialing, marketing and continued use of any medication. This article provides an insight into the growing demands of the pharmacovigilance outsourcing industry, the value it adds to the present day job market and its future trend in India.

hough conventionally viewed only as a subject of academic interest, pharmacovigilance has now evolved as an exciting career opportunity providing immense job satisfaction for aspiring drug safety professionals in India, thanks to India having been recognised as the capital of the Pharmacovigilance Outsourcing industry. The role of a pharmacovigilance team starts from receiving every reported adverse event, evolves through various levels of analysis and ends in the decision-making on how the label of the drugs should read. The meticulousness and diligence of these teams account for the establishment of a high standard of self-regulation in the pharmaceutical industry, in terms of drug safety. Background The World Health Organisation defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Global drug regulations mandate pharmaceutical companies to get their adverse event reports processed by pharmacovigilance professionals and submit the results of their analyses to drug regulatory agencies. A clear understanding of the core science of pharmacovigilance, the intricacies of the stringent drug regulations and sound knowledge of the industry practices are prerequisites for professionals aspiring for a career in this segment.

With recent developments in the regulations of drugs in Europe, there are growing demands to recruit pharmacovigilance/ drug safety, medical information and medical writing professionals who can fulfill the pharmacovigilance liabilities of the pharmaceutical industry. With the advent of contract research outsourcing in the pharmaceutical industry and thanks to Indias leadership on the Information Technology (IT) and ITEnabled Services (ITES) segment, Indians now have the opportunity to pursue an ethical non-compromising career in pharmacovigilance and grow in the corporate ladder to roles that could potentially change the way drugs are used in our day-to-day practice. The global nature of the work ensures international acceptance of the expertise accumulated by pharmacovigilance professionals and some of them would also find themselves working for global drug regulatory agencies eventually. A career in drug safety is very worthwhile and can now headway to other jobs in the pre-clinical, clinical or post-marketing areas of the industry. The time is ripe for aspiring drug safety professionals namely doctors, dentists, pharmacists, paramedical and life science degreeholders in India willing to look at unique natures of work and intellectually challenging medical specialties to grow their career in. Without any doubt, Pharmacovigilance could easily lead the list perennially, as carrying out pharmacovigilance activities is a legal obligation for the pharmaceutical

Dr J Vijay Venkatraman
Managing Director & CEO Oviya MedSafe Pvt Ltd

India has the distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub for Drug Discovery & Development.
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companies which cannot be done away with, at any time. Indian Pharmaceutical Industry The Pharmaceutical industry in India is valued at ` 90,000 Crores and is growing at the rate of 12 14 per cent per annum. Exports are growing at 25 per cent Compound Annual Growth Rate (CAGR) every year. The total export of pharmaceutical products from India is to the extent of ` 40,000 Crores. Indian drugs are exported to around 200 countries in the world including the highly regulated markets of USA, UK etc. India is now being recognised as the Global pharmacy of Generic Drugs and has the distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub for Drug Discovery & Development. Indian pharmaceutical industry is said to reach USD 20 billion by 2015, making it one of the world's top 10 pharmaceuticals markets. It is a highly fragmented market with around 20,000 registered units. These units meet close to 70 per cent of the in-house demand. There are approximately 250 large units and 8000 small scale units which form the core of the pharmaceutical industry in India. In India, a pharmaceutical company holding a marketing license should ensure that they have adequate pharmacovigilance systems in place to take care of the drug safety liabilities of their marketed products, as specified in the Schedule Y. This includes establishment and maintenance of appropriate pharmacovigilance systems to collect, collate and evaluate information about suspected adverse reactions. All these adverse reaction reports and the information about the benefit-risk analysis of all products need to be shared with the Central Drugs Standard Control Organisation (CDSCO). A pharmaceutical

company can achieve this vital step of compliance either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with third party service providers specialising in global pharmacovigilance functions for meeting their pharmacovigilance obligations. Global Spends on Pharmacovigilance The global spends on pharmacovigilance amounted to about USD 12 billion in 2010. According to a Visiongain report, this would be USD 15 billion by 2015, and will continue to grow in double digit till 2021. Regulatory bodies such as the United States Food & Drug Administration

a spurt in the pharmacovigilance job market in India. A typical pharmaceutical company spends more for pharmacovigilance with no revenue from that unit. So, if timelines and quality are taken care of, outsourcing of their drug safety liabilities would relieve the stress of the company and allow them to focus on their core aims of drug discovery development. In fact, the global recession has led companies in the West to largely look at low cost markets for outsourcing their pharmacovigilance activities. Though not as low cost as it used to be, India is a preferred destination for pharmacovigilance outsourcing due to

Global Scenario
Global pharmaceutical market size is USD 880 Billion

Indian Scenario
Indian Pharmaceutical market size is USD 11 Billion

Spend on Pharmacovigilance in 2010 is 12 Billion (USFDA) and the European Medicines Agency (EMEA) are intensifying safety regulations, thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical companies. India as a Pharmacovigilance Powerhouse India is emerging as an important pharmaceutical hub in the world. The adverse event data generated by clinical trials and spontaneous reporting worldwide is enormous and has led to the outsourcing of the pharmacovigilance and pharmacoepidemiology services of the pharma-biotech R&D. This fact is compounded by the increasing number of local clinical trials which has led to

Maturity of Indian market stands at 20% of the Global market the rare combination of acceptable cost, high skill and fluent English. Renowned multinational pharmaceutical companies have eagerly set up pharmacovigilance centers in India either by way of captive units or by forming strategic alliances with pharmacovigilance service providers, thereby generating employment for huge numbers of Indian professionals. Contract research organisations, ITES companies and standalone pharmacovigilance consulting companies are performing very well in India, thereby making it a favored powerhouse of pharmacovigilance for global pharmaceutical companies. Careers in Pharmacovigilance India has a large pool of scientists, clinicians, pharmacists, nurses, dentists and all other life science degreeholders. Those seeking a career in pharmacovigilance are expected to hold a life sciences degree or a nursing,
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Regulatory bodies such as USFDA and EMEA are intensifying safety regulations, thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical companies.

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pharmacy or medical degree. There are also postgraduate courses that could be of benefit to candidates seeking roles in this sector, such as Masters or Diplomas in Pharmacovigilance offered by various training institutes across the country. Pharmacovigilance has a lot to do with on-the-job training and what matters more than the background qualification is the trainability of the candidate in question. Understanding of drug development is vital for any aspiring professional to enter and sustain themselves in this field. For anyone looking to find a job in pharmacovigilance or drug safety, previous experience in the pharmaceutical industry is of great value. Alternatively, a clinical background and first-hand experience with adverse reactions can be advantageous. Therefore, nurses and pharmacists tend to be attractive candidates fornon-medical positions. In a typical pharmacovigilance department or a specialised pharmacovigilance company, there are several positions for medical doctors. Most of the top level positions in such pharmacovigilance departments or companies, as the case may be, are generally offered to experienced medical doctors, since understanding the complete life cycle of adverse effects of medications and making critical decisions on benefit-risk ratio warrants medical knowledge as well as a 360-degree perspective of patient safety. Pharmacy students are the ones most suited for pharmacovigilance jobs by way of background knowledge. They are capable of understanding complex pharmacological mechanisms of actions of newer drugs. Companies prefer to recruit them in almost all segments of Drug Safety except for physician tasks. However, despite having any background qualification, a pharmacovigilance professional can survive only if they constantly update themselves with the dynamically changing regulatory scenario and possess an interest to keep learning new things. Pharmacovigilance offers excellent career growth prospects for doctors as
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A pharmacovigilance professional can survive only if they constantly update themselves with the changing regulatory scenario and possess an interest to keep learning new things.
departments. Apart from outsourced drug safety units, Indian pharmaceutical companies and their pharmacovigilance service providers have started recruiting drug safety staff. With the Indian regulators insisting more on pharmacovigilance capabilities, the recruitment and

well as non-medical pharmacovigilance professionals. A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles,

Pharmaceutical Companies Medical Colleges, Hospitals & Public Health Organisations Pharmacovigilance Consulting Companies Organisations where one can look for pharmacovigilance jobs Contract Research Organisations

Regulatory Agencies

ITES Companies

often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance. Remuneration for a position in drug safety and pharmacovigilance can vary greatly, with factors including the company, the location, the candidate's experience and the requirements of the role. Conclusion Due to globalisation, Indian companies are also gradually investing in pharmacovigilance

work is expected to grow to a great extent. Under the Pharmacovigilance Programme of India, hiring of drug safety professionals is expected to happen at academic institutions and hospitals also. The ever-felt need for pharmacovigilance audits generates careers for independent pharmacovigilance auditors. Hence, the imminent growth of career opportunities in the broader domain of pharmacovigilance is s o me th in g th a t India is entitled to.
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