Course Overview
Pharmacovigilance is a scientific discipline focused on identifying, validating, quantifying, evaluating, and minimizing the adverse effects of therapeutic drugs, devices, or biologics to enhance their safety. Regulatory agencies worldwide, including the US FDA, Indian DCGI, and EMEA, are increasingly strengthening safety laws to adopt a systematic Pharmacovigilance framework. The vast amount of adverse event data generated by clinical trials globally has led to the outsourcing of Pharmacovigilance and Pharmacoepidemiology services in Pharma-Biotech Research and Development. Coupled with the rise in local clinical trials, this has spurred the Pharmacovigilance job market in India.
About the Course
Recognizing the growing importance of Pharmacovigilance and Clinical Research in drug development and patient safety, IBRI NOIDA has introduced a certificate course in Pharmacovigilance available through distance learning and online modes. IBRI offers training led by top industry professionals, aiming to equip students with the necessary skills to start their careers with competitive salary packages. The course covers essential topics such as narrative writing, ADR, ICH guidelines, MedDRA coding, live case scenarios, software training, Argus Lab, and aggregate reporting.
What you’ll learn
- Module 1: Introduction to Pharmacovigilance
- Module 2: Regulatory Framework
- Module 3: Adverse Drug Reactions (ADRs)
- Module 4: Pharmacovigilance Quality and Compliance
- Module 5: Pharmacovigilance Systems
- Module 6: Communication and Ethics
- Module 7: Current trends and case studies
- Module 8: Assessment and Certification
Course Objectives
The OPF Short Term Program aims to provide in-depth knowledge on the best practices for collecting and reporting adverse events and safety data, as well as managing risks associated with pharmaceutical and nutraceutical products. The program’s unique format equips you with the essential skills and knowledge required to operate an efficient and effective drug safety or pharmacovigilance program. These comprehensive online courses in medical writing, pharmacovigilance, and drug safety include examination, enhancing career prospects in the healthcare field.
Eligibility
- MBBS, BDS, BHMS, BAMS, BPT, BUMS
- B. Pharm, M. Pharm
- Pharmacy, Occupational Therapist
- B.Sc., M.Sc.
- Science Graduates
- Life Science, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech
- Professionals working in Hospitals & Healthcare Organizations
Mode of Learning
- Online & Hybrid Mode
Examination
- Offline
Duration of Course
- 35 Hours