Course Eligibility: B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical regulatory affairs and pharmacovigilance.
Features of the Course:
1. Comprehensive study material covering all important aspects of pharmaceutical regulatory affairs and pharmacovigilance
2. Understanding/ Decision Making/ Strategy Creation in the field of pharmaceutical regulatory affairs and pharmacovigilance
3. Pharma Marketing & Regulatory Affairs Case Study (Online Databank) File for effective skill enhancement for strategic decision making
4. Support : Resume Development, Placement Assistance.
Course Duration: 1 Year
Nature of the Course: Distance & e-Learning
- Interactive e-lectures (virtual classroom)
- Online interactive sessions with the expert Industry faculty
- e-Library and e-pharma dictionary
- Access to 1000’s of real life case studies
- Online assignments & self Assessment Test
- Printed Course Material
- 24/7 Online Support With the Live Chat Facility
- Special On demand Modules
- Secure access to e-module with passwords.
- Flexible online final examination (Computer Based Test by secure mode)
- The Internationally Accredited course – Approved by International Association of Distance Learning (IADL), UK
- Personalized web page
- Our courses can be accessed anytime from anywhere
Syllabus: Complete syllabus of Drug Regulatory Affairs and Pharmacovigilance will be covered.
The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.
Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.
The course has been designed and tailored specifically to the needs of research industry.
• Introduction to Clinical Research and Pharmacovigilance
• Global Pharmacovigilance System
• Sources and Documentation of Individual Case Safety Reports (ICSRs)
• Case processing and Reporting
• Medical dictionary (MedDRA) and Medical aspects in Pharmacovigilance
• Special cases in Pharmacovigilance
• Medical Information System
• Safety monitoring in Clinical Trials
• Signal detection
• Periodic Safety Update Reports (PSURs)
• Risk –benefit assessment and management in Pharmacovigilance
• Standard operating procedures in Pharmacovigilance
• Compliance monitoring and Pharmacovigilance inspections
• Global regulatory requirements and guidelines in Pharmacovigilance
• Pharmacovigilance communications
Careers in Pharmacovigilance:
Pharmacovigilance are extremely important functions throughout the development, marketing and continued use of any medication. People in these roles are responsible for monitoring, controlling, processing and reporting the adverse event data obtained from various clinical trials and post-marketing safety. A career in Pharmacovigilance starts with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area.
• DSA (Drug Safety Associate)
• DSS (Drug Safety Scientist)
• Aggregate report scientist
• Team lead or Team manager
• Director or Vice-President
Individuals trained in Pharmacovigilance will find good job options in the following sectors:
• Pharmaceutical Companies (MNCs & Indian) & Biotech companies.
• Clinical Research Organizations
• KPOs like Accenture & Quintiles.
• Regulatory Agencies like CDSCO
• Pharmacovigilance units in Medical colleges & Hospitals
Besides this, students might land up in companies like:
Asian clinical trials serene, Bioserve, Clin invent, Clintec international, Clinigene, Dr Reddy’s lab, Elly Lilly, Glaxo smithkline, IGATE clinical research, Intass biopharmaceuticals, Johnson & Johnson, Lambda therapeutic research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, Siro Clinpharma, Synchron, Sanofi Aventis, Torrent pharma, Vimta labs, Zydus, Reliance life science, Amed, Accutest, Actimus, Adroit insights, Alembic, Paraxel, Mahindra Satyambsg, Aurobindo, Sristek, Shantha Biotechnics, Nektar Therapeutics, Vimta Labs, Biological E. Ltd, Synowledge Pv Services, Biocon, Accenture, Astrazeneca, Bluefish, Sciformix/Strides Acrolabs, Norwich Clinical Services, Hcl, Omnicare, Clinical Research, Micro Labs, Ecron Acunova, G7 Infotech, Cognizant, Tcs and many more companies
Benefits to you:
• CPD Points – Gain Continuing Professional Development (CPD) Points, accredited by The International Association of Distance Learning of the United Kingdom.
• Certification – Receive a personal certificate to show your subject knowledge on course completion.
• Affordable – You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
• Flexibility – The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
• Keep Up to Date – You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.
• Learn from Industry Experts – The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes.