What is Pharmacovigilance?
Pharmacovigilance is a science of Drug safety which is related to the evaluation, prevention of adverse effects, caused by pharmaceutical products. The origin of word “Pharmacovigilance” is from: pharmakon (Greek word: denotes a drug) and vigilare (Latin word: denotes to keep a watch). Pharmacovigilance is at the center stage of new drug development as well as post-marketing evaluation of approved pharmaceutical products. Many drugs are withdrawn from or not even brought into the market because of Pharmacovigilance. It is mainly due to the function of Pharmacovigilance professionals that the medicines in the marketplace that we consume are generally safe. And all those that are identified hazardous are taken off the market. Pharmacovigilance professionals keep a timely watch on the safety of the medicines in clinical trials as well as the medicines previously being marketed in the market. Read A Guide on Medical Laboratory Technician Course.
Aim and objectives of Pharmacovigilance:
- The main purpose of pharmacovigilance is to improve the patient’s safety and enhance his care in terms of the use of medicines, including paramedical interventions.
- Pharmacovigilance also supports public health programs by providing reliable information for the efficient assessment of the risk-benefit profile of medicines.
- Contribute to the assessment of benefits, uses, side effects, harm, effectiveness, and risk of medicines.
- Encouraging the safe, rational and more effective (including cost-effective) use of various medicines.
- Support education, understanding and clinical training in pharmacovigilance and its effective availability to the public.
How do they work?
When the side effect of drugs are reported, the Pharmacovigilance professionals enter the event in appropriate databases, follow-up with the event to collect additional information and send these reports to regulatory authorities and other appropriate regulatory bodies.
Main Activities or Job Responsibilities of Pharmacovigilance Professionals:
- 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 by reconciliation and follow up approach
- Data entry of all details readily available into safety database,
- 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
- Minimising the risk of serious side effects
- Completing safety audits
- Working on the clinical trials of new drug
Opportunities for Pharmacovigilance Professionals
People trained in Pharmacovigilance can find excellent employment options in the following organizations:
- Pharmaceutical Companies (MNCs & the Indian ones) & Biotech companies.
- Contract Research Organizations (CROs)
- Regulatory Authorities such as DCG, FDA & CDSCO
- Clinical Research Organizations.
- Pharmacovigilance Units in Medical Colleges & Hospitals
- Knowledge Process Outsourcing (KPOs) such as Accenture, Cognizant, Sciformix Corporation, iGATE etc.
Besides this, students can make their career with following companies like:
Asian Clinical Trials Serene, Dr Reddy’s Lab, Zydus, Bioserve, Clin Invent, Intass Biopharmaceuticals, Clintec International, Clinigene, Elly Lilly, Lupin Limited, Glaxo Smithkline, IGATE Clinical Research, Johnson & Johnson, Lambda Therapeutic Research, Matrix Laboratories Ltd, Merck, Novartis, Roche India, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Reliance Life Science, Ranbaxy, Sristek, Siro Clinpharma, Synchron, Sanofi Aventis, Torrent Pharma, Vimta Labs, Alembic, Asian Clinical Trials etc.
The initial remuneration for a fresher is significantly based on their academic background, differing from year to year. It also depends on the fact from which organization they had pursued this course.
At a fresher level, employment for pharmacy or life science graduate is Drug Safety Associate. They are primarily engaged in case of creation, reviewing for minimum safety information (MIS).
- After spending 2-3 years of experience in that position and having build the required skill sets (Medical coding, narrative and scientific writing, a good understanding of medical terms and a basic understanding of regulatory affairs, ICH-GCP and compliance etc) he can go on to become a DSS (Drug Safety Scientist).
- Individuals once having acquired a good narrative writing experience can pursue it on a larger frame, moving from individual cases like writing for PSUR (Periodic Safety Update Report) and PADER (Periodic Adverse Drug Experience Reports) and as well as becoming an Aggregate Report Scientist.
- With 7-10 years of experience in this position individuals can easily become a Team lead or Team manager based on the company.
- Lastly, individuals end up acquiring the position of a Director or Vice-President with an experience of 9-10 years.
Average Monthly Pay-scale
- Fresher: Rs 15,000-20,000
- After 5 years: Rs 50,000-60,000
- After 10 years: More than Rs 80,000-90,000
Pharmacovigilance is a great employment option for pharmacy, medical and life science graduates. The main aim of Pharmacovigilance is to provide complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in vivo method. There are large numbers of pharmaceutical and biotechnology industries working in this sector. A pharmacy graduate directly joins this profession, if a person wants to strengthen his/her resume, there are specialized diploma available like professional diploma in pharmacovigilance & pharmacoepidemiology, PG diploma in clinical research & pharmacovigilance, PG diploma in pharmacovigilance & regulatory affairs, PG diploma in pharmacovigilance & medical writing to grab good opportunities.
Students who are willing and have decided to opt for pharmacy as their career are fortunate as nowadays the scope of pharmacy has become multifold. Therefore students desire to be a pharmacist have a huge scope in this field. One of the guiding principles for their success is getting admission in any prestigious pharmacy college.
Check out the article What to do After Passing Class 12.
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