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Online Training - Drug Safety Physician/Medical Reviewer in Oracle Argus Safety Database with Practical Hands on Training with Project Experience Certification & Placement Assistance, Drug Safety Physician Training Argus Safety certificate course in Hyderabad, India consists of online Drug Safety Physician/Medical Reviewer training for the students across the Globe to Countries like India, USA, UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada over World Wide Web. Online Drug Safety Physician Training Medical Reviewer / Periodic Safety Reporting online Training course also offered in Hyderabad, Chennai, Bangalore, Mumbai, Pune, Delhi, Kolkata. BioMed Informatics Medwin Hospitals Online Training complimented as the best Drug Safety Physician Training in Hyderabad, best Drug Safety Physician Training in Chennai, best Drug Safety Physician Training in Bangalore, best Drug Safety Physician Training in Mumbai, best Drug Safety Physician Training in Pune, best Drug Safety Physician Training in Delhi, best Drug Safety Physician Training in Kolkata, best Drug Safety Physician Training in India. Drug Safety Physician/Medical Reviewer online training institute features include Interactive one to one sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Training via Skype/TeamViewer with course material and resume preparation tips.

Online Training - Drug Safety Physician/Medical Reviewer 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 Drug Safety Physician / Medical Reviewer Training in Hyderabad since the year of 2000. Online Drug Safety Physician / Medical Reviewer Training in Hyderabad, India includes best Drug Safety Physician / Medical Reviewer Training online Institute that imparts knowledge about Drug Safety Evaluation. Drug Safety Physician / Medical Reviewer certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Drug Safety Physician Training in USA, best Drug Safety Physician Training in UK, best Drug Safety Physician Training in Australia, best Drug Safety Physician Training in Germany, best Drug Safety Physician Training in Sweden, best Drug Safety Physician Training in Netherlands, best Drug Safety Physician Training in Singapore, best Drug Safety Physician Training in Europe, best Drug Safety Physician Training in Canada. Medical Doctors appearing for Plab1, Plab2, UK GMC Registration, UKMLA, NEET, USMLE Step1, USMLE Step2, Medical Licensing Examinations can widen their career scalability. Training in Online Drug Safety Physician / Medical Reviewer is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. Drug Safety Physician / Medical Reviewer primary responsibility is assessing Drug Safety. With the rising innovations and the rapid growth in healthcare sector, the demand for quality data pertaining to Drug Safety has been increased. Drug Safety Physician, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry.

Career Option for International Medical Graduates as Drug Safety Physicians

The Educational Commission for Foreign Medical Graduates (ECFMG), through its program of certification, assesses whether physicians graduating from medical schools outside the US are ready to enter programs of graduate medical education in the United States. Foreign or International medical graduates (IMGs) in large number try to opt for pursuing a career in medicine in the US. But it is not always possible for all of them to do so. In the case of non-availability of the core medical option, Drug Safety Physician is one of the best option to opt as it is highly demandable area of concern.

Alternative Career Options for Physicians in US

  • Are you an ECFMG certified physician who got unlucky during match?
  • Or are you a board-certified physician who is looking for a career change?
  • Or are you a physician Mom who would like to work from the comfort of your home?
  • Or are you an IMG who is finding it difficult to pass the USMLE exams?
  • Or are you a physician who is tired of the whole residency/match process in the US?
  • Or are you an intern/resident who cannot cope up with the stress during your residency?
  • Or are you simply eager to start a pharmaceutical career?

If your answer to any of the above is "Yes!", let us introduce you to our Online Training - Drug Safety Physician/Medical Reviewer in Oracle Argus Safety Database with Practical Hands on Training with Flexible Timings & Project Experience Certification with Placement Assistance.

United States, Europe and several other countries, are in the process of implementing stringent regulations. This is creating thousands of high-quality jobs for physicians, with excellent growth opportunities, attractive salaries, and several other corporate benefits.

As a medical professional there are considerable issues which need to be addressed to ensure the safety of medicines and medical devices. Medical professionals require substantial understanding and expertise in the field of drug and device safety which will successfully contribute to this through early recognition, management and reporting of the drugs and device safety issues. There are several entry level positions for medical doctors, Viz. Drug Safety Physician, Medical Reviewer and Safety Specialist / Scientist and this leads to higher positions over the years at a fast pace.

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

  • Roles and responsibilities of Drug Safety Physician
  • Roles and responsibilities of medical reviewer
  • 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
  • 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
  • Importance and procedure of duplicate check
  • Data Entry
  • Signal Detection & Risk Management
  • 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

  • Case Quality check
  • Narrative Writing of different cases
  • Medical review of Individual Case Safety Reports (ICSRs)
  • Medical review of narratives
  • Medical assessment of all Serious and Non-Serious Cases
  • Review and modify the data entered in respect of a Case as necessary and in accordance with applicable SOPs
  • 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
  • Report Generation for Regulatory Submission
  • Case Bookin in LAM and Routing to Central Safety database
  • MedDRA and WHO DD coding
  • Different Case Studies
  • Expedited Reports and Aggregate Reports
  • Periodic Reports: PSURs, CTPRs, IND and NDA

You will be extensively involved in Argus Safety

  • Report preparation e.g. Periodic Safety Update Reports (PSURs), Clinical Trial Periodic Reports (CTPRs), PSUR Line Listings
  • Quality checks of aggregate reports,Drug Safety Reports
  • Review of published literature and case listings
  • Performing medical review of individual case safety reports (ICSRs); performing medical review of narratives for Clinical Study Reports (CSRs)
  • Conduct a fullmedical assessment of all serious and Non-Serious Cases; Upgrade a Non-Serious Case to a Serious Case
  • Review and modify the data entered in respect ofa Case as necessary and in accordance with applicable SOPs; and Approve Serious and Non-Serious Cases.
  • Performing QC review of the cases to meet case processing timelines
  • Writing a detailed medically oriented description of the events in the form of safety narrative.
  • Assessment of seriousness, expectedness/listedness of Adverse Events
  • 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
  • Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
  • Processing of all incoming cases in order to meet timelines
  • Perform the duplicate search in Argus safety database
  • Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
  • Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
  • Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to central Argus safety
  • Preparation of PSURs for regulatory submissions

Global Drug Safety Physician Regulations

  • Australia - Therapeutic Goods Administration (TGA)
  • New Zealand - MEDSAFE
  • North America
  • Canada - Health Canada
  • USA - FDA: Food and Drug Administration
  • Central/South America
  • Argentina - ANMAT
  • Brazil - Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Chile - Instituto de Salud Publico (ISP)
  • Columbia - Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
  • Costa Rica - Ministerio de Salud
  • Cuba - CECMED
  • Dominican Republic - Direccion General de Drogas y Farmacias
  • Jamaica - Ministry of Health
  • Mexico - Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
  • Paraguay - Ministro de Salud Publica y Bienestar Social
  • Peru - Ministerio de Salud
  • Uruguay - Ministerio de Salud Publica
  • European Union - EMA: European Medicines Agency
  • Armenia - Scientific Centre of Drug and Medical Technology Expertise
  • Austria - Agency for Health and Food Safety (AGES)
  • Belgium - Federal Agency for Medicines and Health Products
  • Bulgaria - Bulgarian Drug Agency
  • Croatia - Agency for Medicinal Products and Medical Devices of Croatia
  • Cyprus - Ministry of Health
  • Czech Republic - State Institute for Drug Control
  • Denmark - Danish Medicines Agency
  • Estonia - State Agency of Medicines
  • Finland - Finish Medicines Agency
  • France - Agence Nationale de Securite du Medicament et des Produits de Sante
  • Germany - Federal Institute for Drugs and Medical Devices
  • Georgia - Regulation Agency for Medical and Pharmaceutical Activities
  • Greece - National Organisation for Medicines
  • Hungary - National Institute of Pharmacy
  • Iceland - Icelandic Medicines Agency
  • Ireland - Irish Medicines Board
  • Italy - National Institute of Health
  • Lithuania - State Medicines Control Agency
  • Luxembourg - Ministry of Health
  • Malta - Maltese Medicines Authority
  • Moldova - Medicines Agency
  • Netherlands - Medicines Evaluation Board
  • Norway - Norwegian Medicines Agency
  • Poland - The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Portugal - National Authority of Medicines and Health Products
  • Romania - National Medicines Agency
  • Russia - Ministry of Health of the Russian Federation
  • Serbia - Medicines and Medical Devices Agency of Serbia
  • Slovakia - State Institute for Drug Control
  • Slovenia - Ministry of Health
  • Spain - Spanish Medicines Agency
  • Sweden - Medical Products Agency
  • Switzerland - Swiss Agency for Therapeutic Products
  • Ukraine - Ministry of Health
  • United Kingdom - Medicines and Healthcare Regulatory Agency (MHRA)
  • Bahrain - I-SEHA
  • Egypt - Ministry of Health
  • Iran - Ministry of Health
  • Israel - Ministry of Health
  • Jordan - Jordan Food and Drug Administration
  • Lebanon - Ministry of Public Health
  • Saudi Arabia - Saudi Food and Drug Authority
  • United Arab Emirates - Ministry of Health
  • Bangladesh - Directorate General of Drug Administration (DGDA)
  • Bhutan - Drug Regulatory Authority
  • China - CFDA/NMPA: State Food and Drug Administration
  • India - Central Drug Standards Control Organization (CDSCO)
  • Indonesia - POM (Pengawas Obat dan Makanan)
  • JAPAN - PMDA: Ministry of Health, Labour and Welfare
  • Korea (South) - Korean Food and Drug Administration (KFDA)
  • Laos - Food and Drug Department
  • Malaysia - Ministry of Health (MOH)
  • Nepal - Department of Drug Administration
  • Philippines - Department of Health (DOH)
  • Singapore - Health Sciences Authority (HSA)
  • Sri Lanka - Ministry of Health (MOH)
  • Taiwan (Republic of China) - Taiwan Food and Drug Administration (TFDA)
  • Thailand - Food and Drug Administration of Thailand
  • Vietnam - Drug Administration of Vietnam
  • Algeria - Ministry of Health and Population
  • Botswana - Ministry of Health (MOH)
  • Burkina Faso - Le Ministere de la Sante
  • Ghana - Food and Drugs Authority
  • Kenya - Pharmacy and Poisons Board
  • Morocco - Ministry of Health
  • Nigeria - National Agency for Food and Drug Administration and Control
  • Rwanda - Ministry of Health
  • Senegal - Ministere de la Sante et de l'Action Sociale
  • South Africa - Medicines Control Council (MCC)
  • Swaziland - Ministry of Health
  • Tanzania - Tanzania Food and Drug Authority (TFDA)
  • Uganda - National Drug Authority