Online Training on Pharmacovigilance/ Drug Safety in Oracle Argus Software with Practical Hands on Training at Biomed Informatics, Hyderabad
Pharmacovigilance Training Online
Looking for professional pharmacovigilance training? If you hold an associate’s degree or higher and want to advance your career in Pharmacovigilance or want to increase your skillset with the Argus Safety Database, our Online Training – Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Flexible Timings & Project Experience Certification with Placement Assistance is right for you to boost your career. Our Drug Safety Associate training online focuses on ICH-GCP/FDA (US)/EMEA (Europe, the Middle East and Africa)/Canada (Health Canada)/TGA (Australia)/MHRA (UK) guidelines, and hands-on argus safety database training. Unique program designed for professionals aspiring to make a career in Drug Safety using the in-demand, industry-based Oracle Argus Safety Database Software.
- Want to peruse career in Clinical Research & Pharmacovigilance- fill the below form to get information on your mail or phone. If you are interested in such type of training program then fill below form so that a request can be send to training organization for such type of Training Programme
Practical Hands-on Training on Oracle Argus Safety Database
Argus Console
- PV Overview
- PV Business process
- Introduction to Oracle Argus Safety Database
- Family, Product and License creation
- Study creation
- Sites, users and Groups creation
- Workflow Configuration
- Expedited Report Configuration
- Case priority Configuration
- Case Numbering
- Field Validation
- Code list Configuration
- LAM (Local Affiliate Module) Configuration
Argus Safety
- Different icons used during the case processing and their purpose
- Different tabs used in case processing
- Case Routing Based on workflow
- Minimum requirements for a case bookin
- Duplicate case check or verification
- Case Bookin and Data entry
- Case Processing
- Case Quality check
- Medical review of Individual Case Safety Reports (ICSRs)
- Narrative Writing
- Case Bookin in LAM and Routing to Central Safety database
- MedDRA and WHO DD coding
- Report Generation for Regulatory Submission
- Expedited Reports and Aggregate Reports
- Periodic Reports: PSURs, CTPRs, IND and NDA
You will be extensively involved in Argus Safety
- Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
- Processing of all incoming cases in order to meet timelines
- Writing a detailed medically oriented description of the events in the form of safety narrative.
- Perform the duplicate search in Argus safety database
- Assessment of seriousness, expectedness/listedness of Adverse Events
- Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
- Performing QC review of the cases to meet case processing timelines
- Coding of adverse events with the help of MedDRA and labeling the events
- Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
- Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
- Preparation of PSURs for regulatory submissions
- Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to central Argus safety
- Codelist Configuration in Argus console
- Creating Sites, Users, User groups
- Creating Products, Licenses, Studies and Expedited Reporting Rules
- Configuring Workflow States and rules
- Knowledge of Advanced conditions; Setting up of field validation to ensure consistency of data
Certification
Course Certificate & Job Experience Certificate would be awarded at the end of the program.
Course Curriculum
- Clinical Development process
- Different phases of Clinical Trials
- SOPs, Protocol, Investigators Brochure
- Informed Consent process
- SAE reconciliation
- IRB/IEC
- ICH-GCP Guidelines
- History and overview of Pharmacovigilance
- Introduction and responsibilities of USFDA, EMA and CDSCO
- Pharmacovigilance Scenario
- Adverse Events and its types
- Passive pharmacovigilance-Spontaneous reporting
- Active Pharmacovigilance-Cohort Event Monitoring
- Drug Safety in clinical trials and Post Marketing Surveillance
- Different sources of Adverse Events reporting
- Different types of AE Reporting Forms
- Expedited Reporting and its timelines
- Different departments working on Pharmacovigilance
- Roles and responsibilities of case receipt unit
- Roles and responsibilities of Triage unit
- Four factors for the reportable case
- Seriousness criteria of adverse event
- Expectedness or Listedness of adverse event
- Causality assessment of the adverse event
- Signal Detection & Risk Management
- Importance and procedure of duplicate check
- Data Entry
- Case bookin or initiation
- Case processing
- MedDRA and WHODD coding
- SAE narrative writing
- Case quality check, Medical review and its submission
- PSUR and its submission timelines