What is Pharmacovigilance?
Pharmacovigilance is defined as the science relating to the assessment and prevention of adverse effects. It could be any medicine-related problem as well. To put it simply, it emphasizes on drug responses that are adverse in nature. It also caters to medical errors namely over dosage, misuse and abuse of a specific drug. These steps are taken in order to avoid different toxic reactions on a patient.
Pharmacovigilance services work once data is collected from reliable sources namely patients, healthcare providers and medical literature. This data is vital in giving precise results in testing new drugs and checking the adverse effects of pre-existing ones. In the future, pharmacovigilance will tackle two main problems. The first is the identification of risks associated with pharmaceutical products. The second is to lessen the harm caused due to any drugs.
What is the Future of Pharmacovigilance?
The pharmacovigilance industry is growing exponentially because adverse reactions need to be checked in different drugs. A recent report suggests that the pharmacovigilance market is expected to reach 6.1 billion US dollars by the year 2020 and USD 8.33 billion by the year 2025. And according to market research report of pharmacovigilance market size is estimated to grow at CAGR above 12.8% over the forecast time frame 2019-2026 and reach the market value around 10.6 billion USD by the year 2026
The key factor for the expansion of the pharmacovigilance market is the strict drug safety regulations and policies by the governments. In addition to this, the increasing rate of adverse drug reactions has led to a large number of deaths every year. Also, approximately 5% of total hospitalizations are due to these adverse reactions .Therefore, the scope of pharmacovigilance is massive as countries have to come up with solutions to avoid these adverse drug reactions. Apart from this, the pharmacovigilance market is also on the rise due to the increase of chronic disorders as well as the geriatric population base.
To make brighter future in Pharmacovigilance, you need to enroll in Pharmacovigilance Courses to get a best training according to industry from its experts.
Role of Pharmacovigilance
Pharmacovigilance plays a vital role during various stages of the drug discovery and development process. Further analysis of all the adverse events necessitates new safety findings as well as assessments of risks and benefits. In addition to this, it plays an essential role after the drug has been made available in the market. There are many safety reviews namely Risk Management Plan, Periodic Benefit Risk Evaluation Report, the Development Safety Update Report, Periodic Safety Updates Report, Post marketing surveillances, clinical trials and pharmacoepidemiological studies.
The process of introducing a new medicine to the patients is highly time-consuming and expensive process .Therefore; it requires vigilance on the safety and effectiveness of the medicines. Therefore, it is vital to establish good pharmacovigilance practices in order to enhance the drug development .This is done in order to provide patients with safe and effective medicines to meet their medical needs.
The Need for Pharmacovigilance Services
There is a need of pharmacovigilance services in every country. The reason being the difference between the occurrence of adverse drug reactions and other drug related problems in many countries .This may be due to differences in:
- Production of medicines
- Availability of medicines
- Usage of medicines in terms of dosage
- Pharmaceutical Quality
- Compositions of local produced pharmaceutical products
- Usage of herbal remedies that may pose toxicological problems when utilized alone or in combination with other medicines.
Pharmacovigilance services are needed for the avoidance of drug-induced human suffering. Therefore, medicines in the market need continuous monitoring in every country.>
Steps in Pharmacovigilance
An Adverse Drug Reaction could occur during the preregistration or post marketing case of the medicines. They could occur either during clinical trials or be reported promptly by a patient, caregiver doctor, nurse or pharmacist. Since unexpected adverse events could arise anytime in the life of a product. In addition to that, there could be toxic risk to the patient which could result in curtailment of the product. Therefore, safety data is gathered throughout the life of a product. The steps in pharmacovigilance are:
1. Data Collection and Verification
Acknowledgement:A valid case needs to have four elements namely an adverse event, reporter, a patient and a drug. Each adverse effect needs to be acknowledged especially the valid reports. Furthermore acknowledgement establishes a contact with the report additional information when necessary. A reporter will make efforts to send the same report till it is acknowledged. This will minimize the duplication of cases
Duplicate search:Duplicate reports are a common occurrence due to stringent regulations and multiple reporting sources. The safety management software has a provision to identify and delete duplicates. Certain characteristics of a case such as gender, age, date of birth, dates of drug exposure, clinical trial code, and country. This step is of great significance for further processing of the case .It could be possible be follow up information which could divert the seriousness and delay the timeline of the case.
Triage:Triage in the field of safety and management would refer to prioritizing the cases of patients requiring treatment to authorities. In a triage, deaths and life threatening unexpected reports will have to be reported in seven days .Other adverse effects should be reported in fifteen days. There also could be other occasions which would require expedited reporting.
Data entry:The quality of data entry has to be important as it would have an impact on the processing of a case. The case has to be reported meticulously according to certain guidelines. Firstly, the reporter information has to clear and detailed enough to be able to contact the person. The name, formulation and dose of medicines have to be captured correctly. The report has to be detailed enough for the evaluator to decide on the cause of the adverse event.
This would include details such as chronological description of the event or events, nature, localization, severity, characteristics of the event, results of investigations. In addition to these, details of tests, start date, course and outcome, associated medications and other risk factors would be included.
2. Coding of Adverse Reactions:
This specific step would ensure that the data can be shared globally. The commonly used system is the Medical Dictionary for Regulatory Activities (MedDRA). The utilization of MedDRA has led to a global standardization across regulatory agencies, across companies & across countries.
3. Causality Assessment:
Some case reports usually indicate whether an adverse drug reaction is suspected due to the administered drug. In these circumstances, a causality assessment is required to be conducted.
4. Timely Reporting to Authorities:
This is the last step for which all the above has to be done in a timely manner. The reporting could be done either by sending data back to the sponsor of the study or by sending it through the software used in the pharmacovigilance process. The latter will provide an extra couple of days for case processing.
Students can be assured of jobs in various pharmaceutical companies as drug development and safety processes are conducted on a timely basis.Professionals can also advance in their career and earn attractive salary packages, therefore, a career in pharmacovigilance has bright prospects. After successful completion of the Pharmacovigilance courses trainee will find good job option in following sectors:
- Pharmaceutical Companies
- Clinical Research Organizations
- Medical Colleges & Reputed Hospitals
- Regulatory Agencies like CDSCO and DCG
Salary of a Pharmacovigilance Officer
The number of jobs in India is increasing in number .The reason being that more recognition is being given to drug safety worldwide. Fresher can get salary up to 2.8 lakh to 4.2 lakh per annum. Therefore, a professional can get a starting salary of 5 lakh to 8 lakh per annum.
How can I become a Pharmacovigilance Officer?
Candidates need to enroll in clinical research courses to enter the Pharmacovigilance industry. These courses also include practical oriented Pharmacovigilance Training so that students get a hands-on experience of their roles and responsibilities.
To summarize, one needs to enroll in pharmacovigilance courses to start a career in pharmacovigialnce and clinical research.
How can I become a Pharmacovigilance Officer?
The role of a clinical research associate is vital as they are the bridge between clinical trial sites and the organization which sponsors that trial. They supervise the trial from start to finish. Furthermore, they ensure the trial is conducted smoothly by the team. In addition to that, they make sure data is gathered accurately and effectively.
- Clinical Research Coordinator
- Medical Coding/ Medical writer / Medical & Regulatory officer
- Manager –Safety / Patents
- Data Analyst Pharmacovigilance
- Regulatory Affairs Executive
- Clinical trial auditor
- Project manager
- Clinical trial writer
Students also need to know about various sectors in the clinical research industry. Given below are the sectors which you would get job opportunities after the completion of a clinical research course:
- Clinical CRO (Contract Pharmaceutical Companies
- Biotechnology Company
- Clinical Data Management Companies
- Pharmacovigilance Centers
- IT Companies in Healthcare
- Medical & Regulatory officer
- Research Organization
- Data Management CROs
- Packaging, Labeling and Contract Manufacturers
The salary package of a clinical research associate is INR 4,00,203 per year.
Medical Writer❖ Its importance
Medical Writers create varied scientific documents such as regulatory and research-related documents, disease or drug-related educational and promotional literature, content for healthcare websites, health magazines, and news articles. The role of a medical writer is of great importance as they write in language that is understandable to the target audience. The target audiences of medical writers are patients, the general public, physicians, or regulators.
There are some prerequisites required to be a medical writer. These professionals need to understand medical concepts and terminology well. In addition to that, they need to have knowledge of guidelines, structure, and contents of specific documents. Most importantly, they need to have excellent writing skills. They also need to be familiar with researching medical literature, understanding, and presenting research data. Additionally, they need to understand editing and publishing requirements.
❖ Career Prospect
After completion of Clinical Research Courses, there is a huge demand for medical writing in the pharmaceutical and healthcare market. They can work independently or full-time in these sectors. Furthermore, life science graduates can make a successful career in medical writing.
The average salary for a medical writer in India is INR 20,683 per month.
Top 10 Companies
TechnoBridge’s students would get job opportunities in the following companies after their Pharmacovigilance Training.
- Sun Pharma