Pharmacovigilance Overview
Drugs have been formulated and used for hundreds of years but it was only in the 1960’s that it was regarded as essential to carefully monitor the safety of drugs after being marketed. The wake-up call to this realization was the thalidomide tragedy.
Before a drug is marketed, in depth and detailed clinical studies are performed. However, these studies are conducted in a controlled and standardized environment to minimize the risks involved to the study participants.
Once the drug is marketed, it is used in real life situations like diverse populations (e.g. individuals with one or more disease or individuals taking other drugs, children or aged people, genomic or phenomic differences), in other scenarios than the ones of the clinical study, often by millions of patients and for extended durations….. Some rare or unusual adverse events or adverse effects that occur late or with extended are usually only recognized at this moment..
Pharmacovigilance is the vital science and activities associated with detection, evaluation, understanding, reporting and prevention of adverse effects of a health care product. While in the initial five years of a new drug being placed on the market, pharmacovigilance is particularly significant, as relatively little about its safety profile is identified until it is subjected to a much larger population.
The regulatory Authorities ensure patient safety by interacting with healthcare specialists and by tracking the activity of Marketing Authorization companies, in order to evaluate whether they are compliant with pharmacovigilance requirements.
Career Path in Pharmacovigilance
Entry level job for life science graduate is Drug Safety Associate.
Job duties of Drug safety Associate: –
Drug Safety Associate (DSA) handles activities pertaining to the collection, handling, follow-up, evaluation, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed drugs and investigational drugs.
The DSA creates and submits reports to regulatory authorities in compliance with appropriate regulations and ensures that all concerns of the drug regulatory authorities are responded to in a timely manner.
The DSA appropriately responds to queries from health care professionals, customers, and organization personnel concerning safety issues with marketed drugs; create periodic comprehensive written reviews/reports of all given AEs; recognize potential sources of product litigation, get AE data from different clinical trial cases and spontaneous sources; handle case-relevant information such as interpretation of medical situations, lab outcomes, and procedures along with compilation of narrative or summaries; and assure proper coding (MedDRA) into the worldwide AE database.
Professionals who have more than 2 years experience as Drug Safety Associate and skills sets like narrative and scientific writing, medical coding, good knowledge of medical terms and basic knowledge of regulatory affairs, ICH-GCP and compliance etc will have opportunity to become a Drug Safety Scientist (DSS).
Professionals who have good narrative writing experience can do it on a larger frame, moving from individual case reports to writing for Periodic Safety Update Reports(PSUR) and Periodic Adverse Drug Experiences Reports (PADER) and even becoming a Aggregate report scientist.
With over-all 7 -10 years of experience in this entry level position, professional can easily become Team leads and Team managers based on the organization. All you need is to continuously keep yourself updated, improve your skills set and look around for good opportunities.
Pharmacovigilance Career Future
Pharmacovigilance is an evergreen domain in the pharmaceutical industry which will keep on expanding and developing as a major enterprise as more and more countries are laying down elaborate guidelines and processes to comply with. Drug safety budgets have shown a major growth in recent years and it is expected to keep on increasing, as reported in a survey conducted by ‘Cutting Edge Information’. Previously, pharmacovigilance units have spent significant amounts of their time reporting single cases to regulatory agencies all over the world, fulfilling extensively different local specifications. Present developments guarantee that this aspect will be progressively simplified. The powerful development towards international harmonisation will result in considerably more uniform international specifications and the very quick developments in electronic communication will enable automated submission of case reports within organizations and to regulatory bodies.
As the pharmaceutical industry continues to develop more drugs and increase their market base, an increasing number of trained professionals are required to conduct the necessary pharmacovigilance activities in compliance with applicable regulatory guidelines. The huge demand for trained pharmacovigilance professionals is here to stay.
