What is Clinical Pharmacovigilance?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Why Pharmacovigilance is used?
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use and through solicited studies, post medicine is available in the market. It monitors the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function.
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Patient Safety:
The primary goal of clinical pharmacovigilance is to safeguard the well-being of patients participating in clinical trials. Monitoring adverse reactions and unexpected side effects helps ensure their safety.
Risk Identification and Minimization:
By systematically collecting and analyzing data on adverse events and potential risks associated with pharmaceutical products, clinical pharmacovigilance helps in identifying and minimizing potential harm to patients.
Regulatory Compliance:
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive safety data as part of the drug approval process. Clinical pharmacovigilance is essential for meeting regulatory standards and ensuring that new drugs are safe for use.
Quality Assurance in Clinical Trials:
It contributes to the overall quality assurance of clinical trials by identifying and addressing safety concerns promptly. This enhances the reliability of study results and ensures the ethical conduct of clinical research.
Public Confidence:
By proactively addressing safety concerns and ensuring transparency in reporting, clinical pharmacovigilance helps maintain public trust in the pharmaceutical industry and healthcare providers.
Long-Term Monitoring:
Clinical pharmacovigilance extends beyond the initial stages of drug development, providing a framework for continuous monitoring of drug safety even after a product is on the market.
Signal Detection:
It involves the detection of signals or patterns that may indicate previously unrecognized risks or benefits associated with a drug. This helps in refining the understanding of a drug’s safety profile.
Post-Marketing Surveillance:
After a drug is approved and available on the market, clinical pharmacovigilance continues to monitor its safety in real-world settings, identifying and assessing any adverse effects that may not have been apparent during clinical trials.
Global Health Protection:
Clinical pharmacovigilance contributes to global health protection by sharing safety information internationally. This collaborative effort helps address potential risks and benefit a broader population.
Improving Drug Labeling and Guidelines:
Safety information gathered through clinical pharmacovigilance often leads to updates in drug labeling, informing healthcare professionals and patients about potential risks and safe usage practices.
What eligibility should be required?
Basic qualifications includes Undergraduate and/or Graduate degrees in Human Medicine, Veterinary Science, Nursing, Pharmacy, or allied health sciences.
What company can offer jobs?
CRO`s related to Medicines, Biosimilas, Generics etc., Direct pharmaceutical companies etc..
What will be the Average salary?
3.5-25lakhs per annum depends upon experience.
After five years, what will be the growth in Carrier?
Every person can see them in the mid senior level to manager level after 5 years.
What will be the benefit? Placement assistance?
Welcome to RareLight Academy, where education meets empowerment! Joining our courses and classes opens the door to a plethora of benefits designed to shape your future success. At RareLight Academy, your success is our priority. Take advantage of our comprehensive placement assistance program, designed to connect you with exciting career opportunities upon course completion.
