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Drug Safety Physician (Pharmacovigilance Physician)

Drug Safety

Drug Safety Physician (Pharmacovigilance Physician)

The exponential growth of the pharmaceutical industry over the past few decades has resulted in expanding career opportunities for life science professionals. Drug safety monitoring is a vital component of the healthcare system and the data thus accrued defines the duration of the life cycle of a pharmaceutical product. Professionals trained in drug safety management monitor the safety of the medical products to detect and prevent adverse reactions as well as to improve and ensure global safety of public healthcare.

Role of Drug Safety Physician / Pharmacovigilance Physician

Drug safety or pharmacovigilance relates to the science, processes and activities of detection, evaluation, monitoring and understanding safety of medicines followed by prevention and reduction of risk and adverse reactions of medicines and other medicine related problems. Drug safety monitoring is a tedious and continuous process that starts with clinical trials of a new medicine followed by launch of the licenced product in the market and also future monitoring continues as long as it is used by patients.
The drug safety physician in clinical research and development is responsible for implementation of clinical safety strategies and its communication to the team members. Drug Safety Physicians work in coordination with the drug safety team to evaluate performance of the drug and provide future recommendations. In an organisation, drug safety physician should have leadership and communication skills to manage and collaborate between all the members of the team. They are medical expert concerned with managing risk and safety profile of medical products. They are responsible for risk management plans, signal detection and analysis. They ensure implementation of pharmacovigilance system, regulatory compliance and meeting safety timelines.
A Drug Safety Physician should have strong medical knowledge and capable of analysing reports, safety documents, risk management plans, aware of international regulatory guidelines and other requirements. The drug safety physician helps in formulating case study reports, safety data processes, adverse reaction reports and regulatory documents. The functions of Drug Safety Physician are: review benefit to risk profiles, develop safety reports, analyse post-marketing data and clinical trials, identify safety signals, etc. It is a well paid job provided by pharmacovigilance organisations that monitor products under clinical trial followed by post-marketing analysis.

Drug safety physician training

Drug safety physician are involved in clinical research development and launch of medicines in the market. They need to have a medical degree along with excellent communication, organisational, interpersonal and networking skills. Minimum experience of three years in drug safety or pharmacovigilance is necessary. They also should have good knowledge of regulatory requirements pertaining to pharmacovigilance or drug safety.
To induce consumer confidence, product longevity and regulatory compliance, drug safety or pharmacovigilance is an important key. Drug safety courses and training programs primarily focus on creating qualified professionals and cover various aspects of drug safety. The training module includes the history of drug safety or pharmacovigilance; key factors of adverse event reporting in the clinical research; overview of post-marketing; and risk management or signal detection strategies. These training programs recognise that it is essential to develop and market the products without any interruption. Thus, this module provides skills necessary and improves knowledge on drug safety and pharmacovigilance.

Online Courses in Pharmacovigilance and Pharmaceutical Medicine

James Lind Institute (JLI) provides an online programAdvanced PG Diploma in Clinical Research & Pharmacovigilance that provide information on various aspects essential to ensure drug safety. JLI also provides a detailed course in Pharmaceutical Medicine which is designed on the curriculum suggested by The Faculty of Pharmaceutical Medicine of The Royal College of Physicians of United Kingdom.
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