.jpeg "Pharmacovigilance Smart Class")
Pharmacovigilance is one of the fastest growing market as regulator authorities are getting strict in terms of drugs safety issues. India is a hub of Pharmacovigilance outsourcing and there are many CROs now a day. In addition to that, as per March 2016 Gazette notification of India where it is mandatory now for all the Pharma companies to have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant in the country. So, the opportunities in Pharmacovigilance are huge and increasing day by day. In Indian, pharmacovigilance jobs are highly likely  available as India is hub of outsourcing businesses like Clinical trails, Regulatory affairs and clinical research. Job Opportunities after Training: Pharmacovigilance Associates/Drug Safety Associates/Pharmacovigilance Scientists in leading CROs, Pharmaceuticals and healthcare organizations. TRAINING RECOGNITION & ACCEPTANCE: WHO Pharmacovigilance Guidelines International Conference on Harmonization Good Pharmacovigilance Practices Modules TAKE AWAYS: Training completion certificate Recommendation letter for candidates with good performance in training TRAINING SCHEDULE: Sessions: Drug Development Process and Introduction to Pharmacovigilance + Test Pharmacovigilance History and Definitions + Test Pharmacovigilance Terminologies I + Test Pharmacovigilance Terminologies II + Test Assignment: Student will download the Cases and perform to differentiate AE/ADRs, Serious/Non-Serious, Valid/Non-Valid as per instructions and submit. Sources of ICSRs + Test ICSR Processing: Case Receipt, Triage and Follow-ups in Pharmacovigilance + Test Assignment: Student will download the Cases and perform Triage as per instructions and submit. Causality assessment + Test Assignment: Student will download the Cases and perform Causality as per instructions and submit. Narrative writing + Test Assignment: Student will download the Cases and perform Narrative writing as per instructions and submit. Introduction to safety databases and live demonstration of Case processing in safety database ICSR Processing – MedDRA + Test Safety Monitoring & Signal Detection + Test Regulatory Reporting in Pharmacovigilance including Expedited Reporting and PSUR/DSURs + Test Pharmacovigilance Regulatory guidelines – ICH, GVP, 21CFR, Schedule Y and CIOMS + Test Final Assignment: Set of 10 cases will be performed by student and submission. OTHER DETAILS Start anytime Learning Level: Industry Training TRAINING MODE: ONLINE - Self Paced Learning This recorded, self-paced course provides 24/7 access to practical, hands-on training on the modules. Through the training content, practice exercises and assignments, and a final exam, participants complete the course with a strong background of the daily requirements of the Pharmacovigilance professional. ACCESS: 6 Weeks Students have to complete the training in defined time-period by completing all the tests and assignments. TRAINING FEE: 15,000 INR + 2700 (GST 18%) = 17,700 INR DELIVERABLES: Qualified Pharmacovigilance Professional Certification after competency assessment will be issued to participant who successfully completes the program. Procedure: Submit the application form and Payment Students will be given the link for course access Start Learning
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