Introduction

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.  The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation).

Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction. Pharmacovigilance is a huge and encompassing discipline, but we can broadly divide pharmacovigilance into four main sub-specialisms:

Operations: This sector is where many life science professionals interested in drug safety jobs will begin their career. Typical jobs within drug safety operations include case processor, drug safety officer/associate and drug safety manager, and of course team lead and directorships. These professionals will collect and record information during preclinical development and clinical trials, in addition to gathering real world evidence (RWE) of adverse events reported by doctors and patients post-market.

Surveillance: Professionals who focus more within surveillance tend to look towards risk management and signal detection jobs. This also involves performing analysis of the data collated by the wider division. Professionals in this area can hold an array of titles, the most common of which are pharmacovigilance scientist and drug safety physician, but like in all teams, there are many degrees of seniority and remit available. These professionals perform analysis on the drug safety information gathered by the wider department and assist with the creation and review of aggregate reports.

Systems: This division is concerned with the building and ongoing development of a fully robust and innovative system, charged with the responsibility for housing and allowing access (in various forms) to vast quantities of safety data. This safety data is usually collated by those working in operationally focused roles, but is accessed by all. The systems division constantly has to improve, and stay in line with, changing regulations and requirements for the business/ health authorities, making this a very challenging and vital aspect of drug safety.

Qualified Person for Pharmacovigilance (QPPV)

QPPVs jobs are mainly concerned with marketed drugs and those about to be authorized, but as QPPVs are considered by many to be subject matter experts, their expertise is utilized across the discipline and wider business. These senior pharmacovigilance roles will only be held by very experienced professionals and their focus is to understand, plan for and advise upon the regulations and requirements that companies must adhere to across the EU. This is a highly strategic appointment and one of great importance.

The Journal of “Clinical Pharmacology and Toxicology Research” is using Editorial Tracking System to maintain quality and transparency to the author in the peer-review process. Review processing will be performed by the editorial board members of the Journal of “Clinical Pharmacology and Toxicology Research” or by Reviewers (outside experts in the field). Two independent reviewer’s approval (Minimum reviewer’s approval) followed by editor approval is obligatory for acceptance of any manuscript excluding an editorial.

Regards,

Mary Wilson,

Editorial office,

Clinical Pharmacology and Toxicology Research

E-mail: pharmatoxicol@eclinicalsci.com