What is Pharmacovigilance?
Pharmacovigilance is the industry term which refers to the overall safety of pharmaceutical drugs whether they are in the development stage of already in market circulation. It is involved with collecting, recording and analyzing information related to adverse effects that result out of administering drugs to patient populations. The central principle behind the stream of pharmacovigilance is to eventually reduce the risk of any negative effects that may harm patients as a result of consuming drugs. Globally, countries have developed detailed systems of rules and regulations which require pharmaceutical companies that develop and market drugs to work closely with regulatory authorities in order to conduct pharmacovigilance studies which focus significantly on the activity of observing, archiving and reporting ‘Adverse Events’. These ‘Adverse Events’ in simple terms refer to side effects occurring as a result of administering a drug.
Roles and Responsibilities of Pharmacovigilance Professionals
Pharmacovigilance activities are relevant and begin from early stages of the drug development process i.e. clinical development and ideally, continue in earnest throughout the lifecycle of the drug till such time as the drug is in market circulation.
Professionals working in this field carry many interesting titles. The most commonly found job title is that of ‘Drug Safety Associate’ who are entrusted with the critical responsibilities of monitoring, processing, controlling and reporting information on ‘Adverse Events’ obtained through various sources such as the adverse event data which is obtained from clinical trials, healthcare providers, patient feedbacks, medical literature and other sources. Typical activities executed by Pharmacovigilance professionals are listed below for a better understanding.
– Documentation of communication from clinical trial sites such as verbatim call transcripts, faxes, emails, etc.
– Precise and periodic reporting of side effects
– Processing of collected data in company records as per relevant guidelines and laws
– Ensure data accuracy and consistency
– Meet project deadlines
– Understanding, developing, and communicating pharmacovigilance project budgets
– Participate in client meetings and contribute to the discussion from a pharmacovigilance point of view
In the current discussion, we will exclude the career option of Drug Safety Physicians who are qualified medical doctors. Other than them, most pharmacovigilance professionals begin their careers as a drug safety associate or pharmacovigilance officer which are essentially case processing roles. Case processing includes entering patient reported side-effects of pharmaceutical products into a database which is then analyzed and tested by risk management teams. Long term career progression from case processing beginnings usually takes either of the following routes:
Route 1: Line Management
This route consists of successive administrative and supervisory roles aimed at leading and managing large teams. (Examples of designations under this route are senior drug safety officer, manager, director and others)
Route 2: Technical
This route consists of senior roles which include signal detection, risk management and epidemiology roles. (Examples of designations under this route are senior pharmacovigilance scientist, risk management specialist, senior vigilance manager, and others)
As we have seen so far, pharmacovigilance professionals are primarily involved in the activities of recording and storing data in a controlled, consistent, and reproducible manner for the purposes of data retrieval and analysis. This process is significantly facilitated and streamlined through the practice of Medical Coding.
Medical coding is the classification of diverse yet similar verbatim terms, using validated medical dictionaries in order to produce a statistically quantifiable measurement of all similar terms in a given database. In order to achieve consistency and control, many different such dictionaries are utilized to process, analyze and report the data collected. Some of the most widely used and accepted medical coding dictionaries include the following:
– Medical Dictionary for Regulatory Authorities (MedDRA)
– World Health Organization Drug Dictionary (WHODD)
– Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
– International Classification of Diseases (ICD)
– WHO Adverse Reactions Terminology (WHO ART)
Whether you are a final year student on the cusp of graduation, or a working professional already employed in the life sciences industry, it is possible for you to realistically aspire for open positions in the field of pharmacovigilance operations. Since this aspect of the drug development and regulation process is supremely critical on account of being linked with drug safety, professionals working in this field are required to not only get initiated with existing levels of technical knowledge, but, they are also expected to constantly upgrade their skills in order to continue climbing the corporate success ladders which are known for high job satisfaction and satisfying compensation levels.
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