Definition of Pharmacovigilance? What is Pharmacovigilance? And Roles and Responsibilities in Pharmacovigilance
Pharmakon (Greek) = Medical substance
- Vigila (Latin) = to keep watch
History of Pharmacovigilance:
In 1960 Thalidomide drug marketed in 46 countries for hypnotic, prevention of nausea in pregnancy women. 1960 – First reports of deformed infants born (phoecomelia).Total more than 20000 cases were reported.
This Disaster led to amendments and creation of various regulations e.g. FDA, EMA, WHO
What is Pharmacovigilance?
Pharmacovigilance popularly called in short as PV or PhV, Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological, herbalism and traditional medicines ….Reference WHO.
The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic Pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the Pharmacovigilance and Pharmacoepidemilogy services of the Pharma-Biotech Research and Development. This fact is compounded by the increasing number of local clinical trials has led to a spurt in the Pharmacovigilance job market in India
Pharmacovigilance as their career options for ,Medicine,Pharmacy and Life Science freshers ?
- Pharmacovigilance is a great career option for life science and pharmacy graduates. It is a scientific discipline that is primarily concerned with reporting and analyzing of drug side effects. It is primarily due to the work of Pharmacovigilance professionals that the drugs in the market that we consume are mostly safe and those that are found harmful are taken off the market. Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market. After a drug side effect is reported, the Pharmacovigilance professionals enter the event in relevant databases, follow up with the case to gather more information and forward these reports to regulatory authorities and other applicable bodies. The Pharmacovigilance professionals identify signals in data that may point towards a potential side effect and probe the case further.
A Pharmacovigilance professional does the following:
- Track all adverse event reports received and completed;
- Review and assess all source documents, and compile data in an adverse event report;
- Data enter report into the safety database;
- Code adverse events in the safety database;
- Perform labeling assessment of adverse events, comparing adverse event to adverse events previously reported and contained in the product label;
- Release report to safety database
Starting salaries for fresher are substantially a function of their educational background, varying from year to year as well as across organizations and domains.
The following represents the typical work place hierarchy.
- The Entry level job for life science graduate is DSA (Drug Safety Associate). DSAs are mainly involved in case creation, checking for MSI ( Minimum safety information – a patient, a reporter, a suspect drug and a adverse event ), reconciliation and follow-up process, data entry of all information available in the document and medical coding
- Once an individual acquires an experience of 2-3 years in that position and builds the required skill sets (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) he can go on to become a DSS (Drug Safety Scientist).
- Individuals once having acquired a good narrative writing experience can pursue it on a larger frame, moving from individual cases like writing for PSUR(Periodic Safety Update Report) and PADER(Periodic Adverse Drug Experience Reports) and as well as becoming an Aggregate report scientist.
- With an overall of 7-10 year’s experience in this position individual can easily become a Team lead or Team manager based on the company.
- Lastly, individuals end up acquiring the position of a Director or Vice-President with an experience of 9-10 years.
Clinical research jobs and Medical Coding Jobs in Hyderabad are increasing and to meet the current demand of proficient candidates, XCEL CAREER is providing Industry Ready candidates. For your own career oriented goals, you should join institutes with good clinical research training program and Medical Coding Program.
If you are trying to find Clinical Research, Pharmacovigilance, Clinical Data Management, Medical Writing and Medical Coding courses in Hyderabad, XCEL CAREER is one step ahead from your success.
The Clinical Research and Medical Coding training by XCELCAREER are sufficient to make you move ahead in a career in this field of Clinical Research organizations and Medical Coding organizations.