Career in Pharmacovigilance
A drug that enters the human body results in pharmacological effects. Most of the time it helps in the treatment of disease but sometimes it results in noxious and unwanted effects. This adverse unwanted effect leads to different complications in the body and is known as an adverse event. The consequences of an adverse event may be serious or non-serious, severe or not severe depending on various factors. To protect a patient from such adverse events, the properties of the drug should be closely monitored after administration. A process has been developed to monitor this adverse event, which is generally referred to as pharmacovigilance. According to World Health Organization, pharmacovigilance is defined as the science and activities related to the detection, assessment, understanding, and prevention of adverse events or any other possible drug-related problems.
Currently, many pharmaceutical companies in India manufacture various kinds of drug formulations but few have a pharmacovigilance system. The Pharmacovigilance process starts with an event following drug administration, its collection, reporting to drug regulators or competent authority, data analysis, Signal detection, Risk assessment, and risk mitigation. There is a huge scope for a life science graduate to work at different stages of the pharmacovigilance process. Let’s find out one by one.
This is the entry-level job for a life science graduate. PV Associates are mainly involved in the collection of individual case safety reports and sending these reports to regulators. Additionally, they can take part in the review of ICSR received from pharmaceutical companies, and organize training programs for creating awareness about ADR monitoring.
Technical Data Associate
This is a mid-senior level job. The role mainly includes reviewing the PSUR. Generally, the student M.Pharma (Pharmacology), PharmD with 3-4 years of experience can choose this as their career.
This is also an entry-level job for a pharmacy graduate. MV Associates are mainly involved in monitoring the safety of medical devices. They also collect the AEs following the use of medical devices and report this to regulators.
Drug Safety Associate
This is an entry-level job in Pharmaceutical companies or CROs. Most students adopt this career after studying Pharmacy. Drug safety associates are mainly involved in ICSR case creation, data entry from the source document into the software such as Argus, reconciliation, checking for minimum safety information, and follow-up with the patient if required.
Drug Safety Scientist
The candidate must have 2-3 years of experience to reach this stage. The role involves a clear understanding and use of medical coding, ADR terminologies, and regulatory requirements.
Aggregate Report writers
This is a step ahead of drug safety associates. Pharmaceutical companies are required to submit aggregate reports in a periodic interval for a new drug as per Government regulations. Hence their main job is to compile data of a particular period (PSUR or PBRER) and submit it to the regulator with a clear narrative about the safety profile of drugs.
Drug Safety physician
This is mainly for MBBS MD physicians who wish to step into the pharmacovigilance field. The main responsibility is to review the case narratives and causality assessment. They must be well experienced to identify adverse drug reactions.
Signal detection scientist
To become a scientist a minimum of 5 years of Signal Detection experience is required in pharmaceutical/biotech companies. They must be skilled in statistical methodology and results in signal detection Understanding of key data sources used in Signal Detection and Management such as literature and PV In-depth knowledge of procedures, processes, and standards governing pharmacovigilance safety surveillance in different regulatory jurisdictions.
Pharmacovigilance audits are conducted to verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities. Well, an experience physician is preferred for this Auditor job.
Chinmaya Mahapatra, Ph.D.
Associate Professor, IMT Pharmacy College, Puri, Odisha, India