PHARMACOVIGILANCE

With an intent to improve public health, the field of Medicine is growing day by day in terms of new information, research, techniques, drugs, etc. However, there are pros and cons which come as a result of such improvisations, for example, the medicines may lead to an adverse reaction in the patients which may sometimes lead to death. Hence, it is important to improve the patient's safety in terms of the use of medicines and this brings us to the topic of Pharmacovigilance.

Pharmacovigilance, 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 and Vigilare.

IMPORTANCE OF PHARMACOVIGILANCE:

• Improve patient care and safety

• Improve public health and safety

• Promote education and clinical training

• Early detection of unknown safety problems

• Detection of an increase in the frequency of (known) adverse reactions

• Identification of risk factors and the possible mechanism underlying adverse reactions

SKILLS REQUIRED:

• Attention to detail.

• Scientific accuracy.

• Good communication and coordination with various people involved in the process.

• To use a well-planned search strategy relevant keywords and reliable sources.

• Know the target audience and write at a level appropriate to the target audience.

• Ability to understand the purpose and requirements of the project.

• Comprehensive writing skills with good command of English.

• Know basic about MS Excel, MS Word.

ELIGIBILITY:

Life science, MBBS, BDS, BPT, MPT, BSc, MSc, Biostatistics, Bioinformatics, B Pharm, M Pharm, Graduate’s, and Post Graduates.

PROGRAM STRUCTURE:

MODULE 1: INTRODUCTION TO CLINICAL RESEARCH

MODULE 2: NEW DRUG DEVELOPMENT

MODULE 3: DESIGNING CLINICAL TRIALS

MODULE 4: INTRODUCTION OF PHARMACOVIGILANCE

MODULE 5: HISTORY OF PHARMACOVIGILANCE

MODULE 6: IMPORTANCE OF PHARMACOVIGILANCE

MODULE 7: PHARMACOVIGILANCE PROGRAM IN INDIA

MODULE 8: UPPSALA MONITORING CENTER

MODULE 9: ADR REPORTING (SUSAR, PSUR, DSUR)

MODULE 10: MedDRA CODING

MODULE 11: METHODS OF PHARMACOVIGILANCE

MODULE 12: CLASSIFICATION OF ADRS

MODULE 13: DETAILED STUDY OF ADR, AE, AND SAE

MODULE 14: CAUSALITY ASSESSMENT

MODULE 15: PV WORK PROCESS

MODULE 16: POST MARKETING SURVEILLANCE

MODULE 17: OVERVIEW OF ARGUS SAFETY PROCESS

MODULE 18: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

MODULE 19: LIVE PROJECTS BY INDUSTRY EXPERTS