Online Training - Pharmacovigilance/ Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project Experience Certification & Placement Assistance
BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Pharmacovigilance Oracle Argus Safety Drug Safety Training in Hyderabad since the year of 2000. Online Pharmacovigilance Oracle Argus Safety Drug Safety Training in Hyderabad, India includes best Pharmacovigilance Oracle Argus Safety Drug Safety Training online Institute that imparts knowledge about the process of handling data from clinical up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Pharmacovigilance Training in USA, best Pharmacovigilance Training in UK, best Pharmacovigilance Training in Australia, best Pharmacovigilance Training in Germany, best Pharmacovigilance Training in Sweden, best Pharmacovigilance Training in Netherlands, best Pharmacovigilance Training in Singapore, best Pharmacovigilance Training in Europe, best Pharmacovigilance Training in Canada. Training in Online Pharmacovigilance Oracle Argus Safety Drug Safety is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. Pharmacovigilance (PV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Oracle Argus Safety is a Drug Safety Database application for processing, analysing and reporting adverse event cases. It is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. With the rising innovations and the rapid growth in healthcare sector, the demand for quality data pertaining to clinical research has been increased. Pharmacovigilance, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Argus Safety to conduct Clinical Trials.
Pharmacovigilance Training
Pharmacovigilance Is the study of two primary outcomes in the pharmaceutical industry: Safety And Efficacy. Pharmacovigilance is required through the entire life cycle of a drug - starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market. Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.
If you're looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, Drug safety training is crucial. Compliance to European and American pharmacovigilance regulations is important.
Brexit and implementation of the new regulatory base of pharmacovigilance in the UK, as well as in the Eurasian Economic Union (EAEU) countries, have transformed Pharmacovigilance to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Pharmacovigilance has been discussed as a concept for integrated regulations. Considering the recent developments, we are Getting Closer Harmonized systems.
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.
Online Training Features
- Web based classroom
- One faculty/student
- Placement support
- Regular/Fast track/Weekend individual slot
- Flexible timings
- Training Mode: Skype/Teamviewer
- Hands-On Training on the Database
- Direct access to Oracle Clinical Database
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
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
Global Pharmacovigilance Regulations
Pharmacovigilance (PV) regulations focus on monitoring the safety and efficacy of medicinal products. Regulatory agencies worldwide have established frameworks to ensure the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Below is a detailed overview of pharmacovigilance regulations by region and country:
North America
USA
- Agency: FDA (Food and Drug Administration)
- Key Regulations:
- 21 CFR Part 314: Postmarketing reporting of adverse drug experiences
- MedWatch Program: Voluntary reporting for healthcare providers and consumers
- REMS (Risk Evaluation and Mitigation Strategies)
Canada
- Agency: Health Canada
- Key Regulations:
- Guidance for Marketed Health Products (GMPH)
- Adverse Reaction Reporting: Mandatory for MAHs (Market Authorization Holders)
- Canada Vigilance Program
Europe
European Union
- Agency: EMA (European Medicines Agency)
- Key Regulations:
- EU Pharmacovigilance Legislation (Regulation (EU) No 1235/2010
- EudraVigilance: Centralized database for adverse event reporting
- Risk Management Plans (RMPs)
United Kingdom
- Agency: MHRA (Medicines and Healthcare Products Regulatory Agency)
- Key Regulations:
- Yellow Card Scheme for adverse drug reaction reporting
- Adherence to Good Pharmacovigilance Practices (GVP)
Asia-Pacific
India
- Agency: CDSCO (Central Drugs Standard Control Organization)
- Key Regulations:
- PvPI (PharmacovigilanceProgramme of India)
- Schedule Y of Drugs and Cosmetics Act: Adverse event reporting requirements
China
- Agency: NMPA (National Medical Products Administration)
- Key Regulations:
- Adverse Drug Reaction (ADR) Reporting and Monitoring System
Japan
- Agency: PMDA (Pharmaceuticals and Medical Devices Agency)
- Key Regulations:
- GVP Ordinance for Pharmacovigilance System Management
Australia
- Agency: TGA (Therapeutic Goods Administration)
- Key Regulations:
- Adverse Event Reporting Program
- Risk Management Plans
- Latin America
Brazil
- Agency: ANVISA (AgenciaNacional de VigilanciaSanitaria)
- Key Regulations:
- RDC No. 04/2009: Mandatory reporting of adverse drug reactions
Mexico
- Agency: COFEPRIS
- Key Regulations:
- Pharmacovigilance Guidelines for Marketing Authorization Holders
Middle East
Saudi Arabia
- Agency: SFDA (Saudi Food and Drug Authority)
- Key Regulations:
- Saudi Vigilance Program
United Arab Emirates
- Agency: Ministry of Health and Prevention
- Key Regulations:
- National Pharmacovigilance Guidelines
Africa
South Africa
- Agency: SAHPRA (South African Health Products Regulatory Authority)
- Key Regulations:
- Pharmacovigilance guidelines for post-marketing surveillance
Nigeria
- Agency: NAFDAC (National Agency for Food and Drug Administration and Control)
- Key Regulations:
- ADR reporting through the Pharmacovigilance Rapid Alert System
Global Pharmacovigilance Salaries
Pharmacovigilance (PV) salaries vary depending on geographical location, job role (entry-level associate to senior leader), industry (pharmaceutical companies, regulatory agencies, CROs), and the professional's experience. Here's a general breakdown of salaries by region: North America
USA
- Entry-level: $60,000-$80,000 per year
- Mid-level: $90,000-$130,000 per year
- Senior-level: $150,000-$250,000+ per year
Canada
- Entry-level: CAD 50,000-CAD 70,000 per year
- Mid-level: CAD 80,000-CAD 120,000 per year
- Senior-level: CAD 130,000-CAD 200,000+ per year
Europe
United Kingdom
- Entry-level: £25,000-£35,000 per year
- Mid-level: £40,000-£70,000 per year
- Senior-level: £80,000-£150,000+ per year
Germany/France/Netherlands
- Entry-level: £30,000-£45,000 per year
- Mid-level: £50,000-£90,000 per year
- Senior-level: £100,000-£200,000+ per year
Asia-Pacific
India
- Entry-level: ₹3,00,000- ₹6,00,000 per year
- Mid-level: ₹8,00,000- ₹15,00,000 per year
- Senior-level: ₹20,00,000- ₹50,00,000+ per year
Japan
- Entry-level: ¥4,000,000-¥6,000,000 per year
- Mid-level: ¥8,000,000-¥12,000,000 per year
- Senior-level: ¥15,000,000-¥25,000,000+ per year
Australia
- Entry-level: AUD 50,000-AUD 70,000 per year
- Mid-level: AUD 80,000-AUD 120,000 per year
- Senior-level: AUD 130,000-AUD 200,000+ per year
Middle East
UAE
- Entry-level: AED 120,000-AED 180,000 per year
- Mid-level: AED 200,000-AED 350,000 per year
- Senior-level: AED 400,000-AED 600,000+ per year
Saudi Arabia
- Entry-level: SAR 100,000-SAR 160,000 per year
- Mid-level: SAR 180,000-SAR 300,000 per year
- Senior-level: SAR 350,000-SAR 600,000+ per year
Africa
South Africa
- Entry-level: ZAR 300,000-ZAR 500,000 per year
- Mid-level: ZAR 600,000-ZAR 1,200,000 per year
- Senior-level: ZAR 1,500,000-ZAR 3,000,000+ per year
Nigeria/Kenya/Ghana
- Entry-level: $12,000-$25,000 per year
- Mid-level: $30,000-$50,000 per year
- Senior-level: $60,000-$100,000+ per year