Be vigilant

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Be vigilant

Wednesday, 13 March 2019 | Chandrashekhar D Bobade

Be vigilant

With the advancement of pharmacovigilance, CHANDRASHEKHAR D BOBADE talks about the scope and prospects of the programme

The simple meaning of word pharmacovigilance is to keep watch on drug’s fate. WHO (World Health Organisation) says pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Essentially making the field of Pharmacovigilance a science related to drug safety with regards to the adverse effects it can result in.

Today, pharmacovigilance takes center stage whenever a new drug is developed. These professionals keep a close eye on new drugs during its clinical trials and even test medications already on the market. A lot of drugs are either withdrawn from the market or never allowed into the market thanks to pharmacovigilance. It is thanks to these professionals that the medications that the general public consume are generally safe.

Therefore, we can conclude that the main aim of pharmacovigilance is to:

  • Improve patient safety
  • Enhance patient care in terms of medicines used
  • Contribute to the evaluation of advantages, applications, side effects, harm, effectiveness, and risk of medicines
  • Encourage safe, balanced and effective use of various medicines

The next question is how do pharmacovigilance professionals work?

 Let’s imagine for a moment, that people have started reporting serious side-effects after consuming a drug named XYZ. When such side-effects are reported, pharmacovigilance professionals step in to collect the right data by recording the side-effects of medication and talking to the patients and healthcare professionals in this situation. Then they create a report and send this report to the right regulatory authorities or bodies. 

Since the necessary introduction of pharmacovigilance has been done, let’s dive deeper into this career path and evaluate what a professional can expect in this field.

According to Business World, India is one of the third largest producers of pharmaceuticals. The pharmaceutical industry in India is expected to reach $55 billion by 2020. Therefore, it’s easy to see why pharmacovigilance professionals in India have a bright career ahead of them. People that have studied pharmacovigilance can find employment in various organisations like:

  • Pharmaceutical Companies (MNCs & the Indian ones) & Biotech companies
  • Contract Research Organisations (CROs)
  • Regulatory Authorities such as DCG, FDA & CDSCO
  • Clinical Research Organisations
  • Pharmacovigilance Units in Medical Colleges & Hospitals
  • KPOs (Knowledge Process Outsourcing) such as Accenture, Cognizant, Sciformix Corporation, iGATE etc.

According to Career India, some of the top pharmaceutical companies recruiting pharmacovigilance professionals are — Dr Reddy’s lab, Cipla, Ranbaxy Laboratories, Johnson & Johnson, Matrix Laboratories Ltd, Pfizer, Ranbaxy, Asian Clinical Trials, Merck, Clinigene, Novartis.

Initially, the remuneration that a fresher may receive depends on his academic background. Therefore, a degree from a reputed university is important. As a fresher who has studied pharmacy or life science, you will be involved in creating a case when required, and reviewing medications for minimum safety information.

After two to three years you will have built various skill sets like medical coding, narrative and scientific writing, a good understanding of medical terms, understanding of various regulatory affairs, and more. These skill sets will allow you to move up to becoming a DSS (Drug Safety Scientist)

You could also, after learning how to be a good narrative writer choose to pursue a career as a writer or PSUR (Periodic Safety Update Report) and PADER (Periodic Adverse Drug Experience Reports). Furthermore, you could also choose to become an Aggregate Report Scientist.

After about seven to ten years of experience, you can also work as a team lead or manager depending on the organisation you work for. Lastly, with a background of nine to ten years, you can also acquire positions like Director or Vice-President in an organisation.

How to pursue a career in pharmacovigilance: Aspirants who have graduated from life sciences degree like pharmaceutical sciences, medical, biotechnology, microbiology, biochemistry, genetics and others are eligible to pursue a course in pharmacovigilance. You can also choose to pursue a diploma course in pharmacovigilance after your graduation. However, the duration of these courses can vary.

In conclusion, pharmacovigilance is a fantastic career opportunity for pharmacy, medical, and life science graduates. You will spend your career researching drugs that can be potentially harmful to the general public. Thereby, you will be a person saving lives from behind the curtains.

The writer is Assistant Professor,MIT School of Pharmacy

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