Pharmacovigilance is a science of detecting and reporting adverse drug reactions, adverse events, and abnormal laboratory findings.
Prior to release into the market, all new medicines/ medical devices must have completed a series of clinical trials with patients. These trials are aimed to establish the safety and efficacy of the drug for the treatment of a particular disease within a selected sample of the population. However, even after having completed rigorous pre-marketing trials, there are limitations in detecting adverse events and drug reactions. The less common adverse reactions (ADRs) are statistically unlikely to have been detected. Once the product has been placed on the market, the general population is exposed to the new product for the first time wherein the effectiveness of the product can be studied. Pre-marketing studies of a drug may also exclude certain groups of patients, although, in real-life clinical practice, the drug may be prescribed for patients from those groups.
For example, clinical trials may have patients aged 18 to 60 years old. However, the drug may be prescribed to more elderly patients. The elderly are a population that are more sensitive to a range of adverse reactions of medicines for various reasons, including differences in metabolism and in body mass index compared with a younger population. Vulnerable subjects with co-morbidities like renal or cardiac impairment, immunodeficiency, or blood pressure anomalies, etc are not included in the clinical trials. There is a chance that the drug could be contraindicated or close monitoring may be required.
Polypharmacy is another issue that may not have been possible to adequately address during pre-marketing studies. Drug-drug interactions with the concomitant medications is possible and this is kept in mind while selecting subjects for the trial. When the drug is in the market these kinds of patients cannot be excluded from taking the drug.
In the field of Pharmacovigilance, there is a huge amount of data reported and each and every report has to be analyzed. Therefore, the requirement of professionals to do the various Pharmacovigilance activities have also increased tremendously. This in fact opens a great opportunity for life science, pharmacy, nursing, or medical and dental graduates seeking career opportunities in pharmaceutical companies, contract research organizations (CRO), or business process outsourcing (BPO) companies or regulatory bodies.
Due to the current scenario of COVID pandemic, people are looking for a better opportunity of long term career options in a recession free industry. The latest reports on Clinical Research reveal that soon there will be a 20 fold surge from 250 crores to 5000 crores in the pharmaceutical sector. The various e-learning Pharmacovigilance course offered by our nation will definitely provide new career prospects for the aspirants of the healthcare industry.
Pharmacovigilance aspirants can pursue pharmacovigilance courses online like Certificate Course in Pharmacovigilance, Advanced Post Graduate Diploma in Pharmacovigilance. The module of Pharmacovigilance dwells on Narrative Writing, Risk Management Plan, Good Vigilance Practice, PvPI, etc. with a comprehensive understanding of regulatories globally.
The current COVID situation has changed our lives and made us think about alternate options in the learning process. It has opened the window to explore more on e-learning, where students can learn at home with the help of virtual and online training at their own convenient time.
AVIGNA CLINICAL RESEARCH INSTITUTE (ACRI), provides the best pharmacovigilance online course in Bangalore like Certificate Course in Pharmacovigilance and Post Graduate Diploma in Clinical Research which covers Clinical Research, Quality Assurance, Data Management, and Regulatory Affairs. Our curriculum is developed for online knowledge sharing and skill training that substitutes classroom programs. Our online classes allow students to easily interact, discuss, and share information with faculty and fellow students. These job-oriented courses train aspirants in pharmacovigilance and provide excellent career opportunities with an industry-specific curriculum based on case studies using experts in teaching faculty at ACRI.
Eligibility criteria for clinical research programs offered by our institute include graduates and postgraduates in pure science, health science, and all other allied sciences. ACRI’s experience in the field of clinical research goes a long way in providing the best training with hands-on experience using in- house PV software. Avigna has developed a unique PV software with a user manual and case processing guide for the students to get trained in case reporting and narrative writing. This will help our students to perform better when they are placed in any clinical research organization. Placement support is an added feature. ACRI’s training helps to boost a career in pharmacovigilance or even to upskill for an extra edge over other candidates, both in terms of knowledge as well as performance during the interview. A conscious effort must be made to make yourself more competent if you wish to succeed.
Career opportunities in the clinical research program in India are plenty. Trained personnel in clinical research are well-positioned to join the industry as a clinical research coordinator, clinical research associates, data specialist, investigator, project managers or medical/scientific writers. These roles include the responsibility of reporting and monitoring product safety and duties related to detection, assessment, and prevention of adverse events associated with drugs. Responsibilities and duties progress to a senior specialist or management roles with an in-depth knowledge of specialty areas of quality assurance, auditing, regulatory affairs, or medical and scientific writing.
Training at ACRI with customized pharmacovigilance programs would prepare a health science or pharma graduate to take on the challenges of pharmacovigilance and earn attractive and handsome packages in this field. Equipped with ACRI’s clinical research program online, one could get the long-cherished financial freedom with a starting package of 3 lakhs/annum.
As there is a huge demand for research in the present COVID -19 crisis, understanding the basics of clinical research, clinical data management, and pharmacovigilance would help you to leave your footprints in this field and create an impact on mankind.
