Pharmacovigilance Courses Fees, Career, Role, Future & Salary

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.

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.

Career Prospects

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
• KPOs
• Clinical Research Organizations
• Medical Colleges & Reputed Hospitals
• Regulatory Agencies like CDSCO and DCG