Qualified Person Responsible For Pharmacovigilance Training – QPPV Training

Pharmacovigilance Training

The role of Pharmacovigilance is to ensure patients safety by continuously monitoring and preventing adverse reaction of drugs. The rise in pharmacovigilance activities worldwide has resulted in an enormous demand for skilled and trained professionals in the field.

Pharmacovigilance Training

Pharmacovigilance systems strives to protect the health of patients by safer use of drugs, therapies and medical devices. Professionals working in this field need to have knowledge of drug safety, regulatory guideline and strategies for risk management. Pharmacovigilance report system collects, organizes, processes and analyzes data related to drug safety or pharmacovigilance. To facilitate the implementation and performance of pharmacovigilance, training programs are necessary.

Training courses provide complete training solution based on various appropriate guidelines to help individuals acquire knowledge and skills required in the field of pharmacovigilance. The courses are consistent with guidelines of pharmacovigilance or drug safety, regulatory and quality compliance. They are designed with interactive presentations for easy and better understanding of Good Pharmacovigilance Practice (GVP).

To facilitate the performance of pharmacovigilance, set of measures called GVP are designed. The objective of such programs is to impart the fundamentals of good pharmacovigilance; present legal or regulatory guidelines; outline GVP requirements, risk management systems and documentation related to GVP like the study protocol, pharmacovigilance system master file (PSMF) and periodic safety update report (PSUR).

Qualified Training Personnel for Pharmacovigilance

Pharmacovigilance is a field that needs experts in areas of medical research, regulatory affairs and marketing. Training programs have a well defined curriculum delivered by experts that can help create skilled and trained pharmacovigilance personnel for the industry. The training programs can help in increasing productivity, problem solving capacity and help adapt to any future changes with respect to the job. Educational programmes and seminars in pharmacovigilance have been offered by a range of institutes and societies to educate and train aspiring individuals. These courses will benefit the professional aspiring to work in pharmacovigilance department of regulatory bodies, pharma and healthcare industry.

Pharmacovigilance specialists can aspire to positions such as senior specialist, project leader, manager, director, consultant and trainer or educator. The specialist should be competent in all the topics covered under pharmacovigilance and its global relevance. The experts and trainers have co-operated and coordinated to create a detailed, comprehensive and balanced curriculum with specific relevance to regulatory and industrial requirements so as to provide theoretical and practical knowledge of the field.These personnel help and guide the participants during the training process and have experience in clinical practice, laboratory work, teaching, etc. They impart training in important aspects of pharmacovigilance like drug safety monitoring, diagnosis, reporting and preventing adverse events as well as risk assessment or management. The teaching and training experts should have in-depth education and widespread knowledge in such areas.

The pharmacovigilance specialist needs to have degree in health science with fluency in English along with more than two years of experience in pharmacovigilance, regulatory affairs or clinical research. They should have good communication, decision-making, problem-solving and analytical skills. They should be team players, capable of working on many projects simultaneously and meeting deadlines even under pressure. They should be responsible, confident and portray mutual respect. Other virtues that can benefit the training program are being versatile, meticulousness with attention to detail and organized.

Online Course in Pharmacovigilance

James Lind Institute (JLI) provides an online programAdvanced Post Graduate Diploma in Clinical Research and Pharmacovigilance that helps create more professionals through guidance from experts in the field of pharmacovigilance.

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