Showing posts with label Pharmacovigilance Training. Show all posts
Showing posts with label Pharmacovigilance Training. Show all posts

Wednesday, 20 May 2015

Awesome Job Prospects in Pharmacovigilance

Pharmacovigilance has become an attractive career option for pharmacy and lifescience graduates. It involves the identification, validation, assessment and evaluation of adverse drug events post marketing.
What is it?
The safety of the medicines that we consume is all thanks to the pharmacovigilance officers who ensure that the drugs in the market are safe. They continuously monitor the safety of medicines both under clinical trial and those already released in the market. When a side effect of a drug is reported, they record these in the safety database, follow up for more information, report the case to regulatory authorities and probe the incident further. In short, they make sure that the drugs in the market are safe.
Pharmacovigilance Market – Bright Indeed
A large number of jobs in the pharmacovigilance sector have been generated because of the adoption of a worldwide systematic pharmacovigilance framework owing to international regulatory bodies. In 2015, the worldwide pharmacovigilance market is estimated to reach $2,253 million. Since India is the fourth largest manufacturer of pharmaceuticals and has over 6,000 licensed pharmaceutical producers, it offers great prospects for the growth of the pharmacovigilance sector. Some of the advantages include the presence of a large number of patients with abundant genetic diversity, a large world scale ADR (adverse drug reaction) database, and rapid introduction of lakhs of drug formulations into the domestic market.
Job Outlook and Salaries
The starting salaries for pharmacovigilance professionals depend on the educational background, hands-on experience, etc. and vary yearly as well as across organizations. Typically, DSA (Drug Safety Associate) is the entry level job. The job profile involves creation of cases, checking minimum safety information, reconciliation, follow up, data entry and medical coding. Freshers are paid anything between Rs. 15000 to Rs. 20000. After a 2-3 year experience, a DSA can be promoted to the role of a DSS (Drug safety scientist). DSSs are required to be very good in understanding ICH GCP compliance, regulatory affairs, scientific writing and medical coding. Those crossing 5 year experience in the sector can expect salaries between Rs. 50000 and Rs. 60000. Upon acquiring a good experience in narrative writing, pharmacovigilance professionals can move on from singular cases like writing for PADER (Periodic Adverse Drug Experience Reports) and become an Aggregate report scientist. Those with 7 to 10 years’ experience can be promoted to the position of a team lead followed by the position of a vice president or director.  After ten years of experience, pharmacovigilance professionals can expect salaries over Rs. 80000 to Rs. 90000.
Pharmacovigilance professionals are usually employed in clinical research organizations, pharmaceutical companies, KPOs, biotech companies, regulatory agencies and pharmacovigilance units in hospitals. They may also get placed in companies like Novartis, Merck, Bioserve, Clinigene, Johnson & Johnson, Ranbaxy, Sanofi Aventis, Pfizer and Reliance Life Science.
Those in this field can find lucrative jobs with attractive salaries. The pharmacovigilance industry in India is still budding and is yet to reach the levels required to be on par with other countries. However, this initial stage of the industry means that there are a lot of vacancies to fill.



Thursday, 14 May 2015

Pharmacovigilance Training and Job Opportunities

Pharmacovigilance involves the assessment, detection and prevention of long-term and short-term adverse effects of medicines. Because of the serious nature of the profession, it requires expert pharmacovigilance training. As a pharmacovigilance professional, one would be required to collect, research, monitor and evaluate information from patients and healthcare workers on the side effects of medicine in order to discover new hazards of a medicine.

The pharmaceutical industry has undergone large scale globalization and there has been an increasing awareness of drug safety issues. Because the need for pharmacovigilance in India is expanding as the drug Research and Development segment is expanding, there is an increased demand for pharmacovigilance courses. India ranks fourth in the world for the production of pharmaceuticals with over 6000 licenced manufacturers of drugs and more than 60000 branded formulations. It is also a lucrative industry for clinical trials and post-marketing surveillance of approved drugs. Pharmacovigilance is important during the initial years of launch of a medicine when drug safety information is acquired from a larger patient pool.

Eligibility for Pharmacoviligance Course
Any life-science graduate is eligible for pharmacovigilance training. Doctors, pharmacy graduates and postgraduates, other professionals from the pharmaceutical industry, clinical research professionals are also eligible.

Pharmacovigilance Course Curriculum
Most pharmacovigilance training courses teach the basics along with risk management, clinical safety and regulations compliance, safety reports and adverse drug reactions, regulations concerning clinical trials, pharmacovigilance management and signal analysis. The aim of pharmacovigilance course is to enable students understand the benefits and risks of drug use, manifestations of adverse drug effects, detection of adverse drug reactions, and their associated legal and historical frameworks.

Career Prospects after Pharmacovigilance Training
The pharmacovigilance industry has a huge potential for growth and success. A pharmacovigilance officer’s role begins right from the initiation of preclinical studies and extends even after the marketing of the drug is complete and it is under circulation. The drugs are evaluated for adverse reactions in a limited pool of patients before being marketed to a larger pool. It is thus essential to identify and detect adverse drug reactions of medicines after it is marketed to patients. It is thus essential to pay great attention to what is taught in a pharmacovigilance course because of the meticulous nature of the profession. A pharmacovigilance officer is responsible for detecting, assessing and preventing adverse drug reactions or other medicine-associated problems and side effects, both in the longer term and short term. After the completion of pharmacovigilance training, one can be employed as a Clinical Pharmacovigilance Associate, a Pharmacovigilance Manager, Regulatory Affairs Associate, Analyst, Pharmacovigilance  Monitor or Pharmacovigilance Officer.
The job profile of a pharmacovigilance professionals involves tracking of adverse reaction event reports received, reviewing and assessing source documentation, compiling data in reports on adverse events, entering data into safety database, coding adverse events in the database, labelling and comparing adverse events with previously reported events and releasing reports into the database.
Ikya Global is one of the few best pharmacovigilance training institutes in Hyderabad that offer training at affordable prices along with placement assistance and certification.