Pharmacovigilance (PHV or PV) called as drug safety is the activities of life science concerned to the detection, collection, assessments, understanding, monitoring, and prevention of the drug related adverse effects or problems. It is a broad term considered to be a complete scientific and process-driven area within pharma industry. PHV is majorly considered within two outcomes which include safety and efficacy. The study almost touches all the aspect of the drug lifecycle – from preclinical development to post-market surveillance. The primary aim of the pharmacovigilance is the patient care and safety in relation to the medicine uses and also support all the public health programs by offering consistent, reliable and balanced information for effective assessment of the risk-benefit profile of medicines. Information received from healthcare providers and patients from the via pharmacovigilance agreements (PVAs) and also the other sources such as medical literature, plays a significant role in offering the information required for the pharmacovigilance to take place. Most of the companies conduct a comprehensive drug safety and pharmacovigilance audit to evaluate the compliance with worldwide laws, rules & regulations, and guidance.
What are the main areas of pharmacovigilance?
Pharmacovigilance is broadly classified into four key sub-specialisms, which include:
- Qualified Person for Pharmacovigilance (QPPV)
Operations: This sector is majorly for the life science professionals interested in drug safety jobs. The jobs within the drug safety operations include drug safety officer/associate, case processor, drug safety manager, and of course team lead and directorships. The job role of these professionals is to collect and record information during preclinical development and clinical trials. They also gather the real world evidence (RWE) of adverse events reported by doctors and patients post-market. Furthermore, they are also responsible for creating individual case study reports, standard operating procedures (SOPs), regulatory expedited reporting, and literature screening.
Surveillance: This sector includes the professionals focusing more on the surveillance tend to look towards risk management and signal detection jobs. The job role involves the performing analysis of the data collated by the broader division. The professionals in this sector perform analysis on the drug safety information gathered by the wider department. Additionally they also create periodic benefit risk evaluation reports (PBRER) for post-market drugs and development safety update reports (DSURs) for drugs in clinical research. These reports helps the team to get the conclusions around the safety and efficacy of a drug or candidate molecule.
Systems: This sector is majorly concerned with the building and ongoing development of a fully robust and innovative system. The professionals are primarily responsible for the housing and allowing access (in various forms) to vast quantities of safety data. These professionals have to be constantly improve and stay in line with changing rules & regulations and requirements for the health authorities or businesses, thus making a challenging and a vital aspect of drug safety.
Qualified Person for Pharmacovigilance (QPPV): In this sector the professionals are primarily concerned with marketed drugs and those about to be authorized. The senior PHV roles will only be held by experienced professionals and their center of focus is to understand, plan and advise the regulations and requirements that companies must adhere. This is a highly strategic appointment and one of great significant.
Significance of the Pharmacovigilance
Pharmacovigilance is the most important function within a life science company. To progress, manufacture and commercialize a pharma company must follow to strict rules & regulations. Most of the rules & regulations will concentrate on the patient’s safety and the benefit to the patient derived from the drug.
Following are the factors for the significance of pharmacovigilance:
- Patient safety and continuous vigilance: Drug safety guarantees that a patient’s safety and wellbeing is safeguarded throughout the entire drug development lifecycle. Drugs are constantly monitored for other side effects on patients, and any new information received is collected and reported to health authorities on a regular basis. Other areas concentrate on improving the patient lives in all, and no other department has such focus as an end-point on safety.
- Power and authority: The vigilance mean that, senior professionals and leaders within a drug safety team have the authority and responsibility to endorse a development process is stopped, or that an approved drug is pulled from the market.
- Keeping it moving: Drug safety helps to save and keep the wheels of a pharmaceutical company moving. The drug safety means that it functions on a very cross-functional basis by following the all government applied rules and regulations. Thus, the impact and value which the division can add to other aspects of the business is remarkable.