- Join our Upskilling Courses. Exclusively for Experienced Pharmacovigilance & Medical Writing Professionals
PHARMACOVIGILANCE COURSE-ADVANCED
Pharmacovigilance is of the interesting and Challenging fields a Life science graduate can pursue is Pharmacovigilance. Pharmacovigilance or Drug safety is one of the most critical steps involved in the drug development and Clinical trial process. It mainly involves the collection, analysis, monitoring, and prevention of adverse effects in drugs and therapies. It is present to make sure the patient’s wellbeing is taken care of throughout the Drug Development Cycle.
3 Types :
Weekend Batch : 3 Months
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)
25,000 RS for Indian Students.
30,000 RS for NRI Students.
1. What is the Qualification For Doing this course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Pharmacovigilance Job : From 15000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Pharmacovigilance : Progressive & Prosperous.
10. Is there any abroad Opportunities For Pharmacovigilance : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance jobs.
COMPUTER SYSTEM VALIDATION
Computer System Validation (CSV) is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the integrity of its data to ensure the safety and effectiveness of the product.
Detailed understanding on US FDA and EMEA requirements for Computer System Validation, Electronic
signatures, Part 11 compliance and signatures.
GAMP 5 Classification: Simplified! – Risk Management approach and principles for Part 11 compliance
Audit Trials:Demonstrating Data Integrity via Documentation and Audit Trails
Backup: Backup and Restoration procedures in detail.
Regulatory Requirements:In depth guidance on translating the regulatory authorities expectations and communicating with them
effectively through interactive sessions.
Total 20 hrs. (+ 5 hrs. Post-training queries support over TC)
25,000 RS for Indian Students.
30,000 RS for NRI Students
What is the Qualification for doing the course:
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Computer System Validation Job : From 20000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Computer System Validation : Progressive & Prosperous.
10. Is there any abroad Opportunities For Computer System Validation : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Computer System Validation jobs.
ARGUS SAFETY FOR ADMINISTRATORS
Argus Safety assists manufacturers of pharmaceuticals and devices by providing a simple and efficient way to comply with international and domestic regulatory safety reporting requirements.
Module – 1: Argus Safety Configuration
Codelist configuration :
Argus Console overview.
Codelist configuration.
Flexible Data Re-categorization configuration.
Business configuration :
Business configuration overview.
Company products configuration.
Regulatory reporting rules configuration.
Studies configuration.
Access management :
Access management overview.
Users configuration.
Sites configuration.
Group configuration.
System configuration :
System Configuration overview.
Case priority setup.
Field validations configuration.
Field properties.
Argus system case numbering setup.
System Management.
Workflow configuration.
SMTP configuration and it’s uses.
Module – 2: Argus Safety Technical Aspects:
Argus Safety Architectural Overview and Details :
Argus Safety Web Server.
Argus Safety Services.
Argus Interchange overview.
Axway (E2B) Gateway overview.
Argus Safety Troubleshooting Tips :
AG Service Configuration and Logs.
ESM Service Configuration and Logs.
SQL TIMES.
Error Log.
2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)
35,000 RS for Indian Students.
40,000 RS for NRI Students.
What is the Qualification for doing the course:
B. Tech/ M. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
MATERIOVIGILANCE
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient’s health by preventing its recurrences.
- Medical Device Course Overview
- Introduction to Medical Devices Course
- Scope for Medical Device Writing& Companies Offering
- Differences B/W Devices and Drug Writing
- Overview of MedDev Rev 4 Guidelines
- Regulations of MDD and MDR
- Overview of Clinical Evaluation Report
- Overview of Other Medical Device Regulatory Documents
- Claiming Equivalency to Medical devices
- State of the Art
- Appraisal and Writing Literature Summaries
- Risk- Benefit Analysis
- PMS and PMCF
- Overview of IVDR
3 Types :
Weekend Batch : 3 Months
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)
20,000 RS for Indian Students.
25,000 RS for NRI Students.
What is the Qualification for doing the course:
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
1. What is the Qualification For Doing the course:
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Materiovigilance Job : From 20000 RS per month to 23000 RS/26000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Materiovigilance : Progressive & Prosperous.
10. Is there any abroad Opportunities For Materiovigilance : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Materiovigilance jobs.
MEDICAL WRITING
Medical writing is a profession dedicated to the communication of medical, scientific, and health information,
including research reports, patient information, and regulatory documents.
- Introduction to Medical Writing.
- Clinical Trial Terminologies and Definitions.
Clinical:
- Clinical Trial Protocol.
- Clinical Study Reports.
- Informed Consent Form, Case Record Form.
Regulatory/Labelling:
- Preparation of PIL/PI/SmPC.
- Clinical and Nonclinical Overviews and Summaries.
- Justification document, Addendum, Bio-waiver Justification.
- Core Data Sheet/ Core Safety Information.
Publication:
- Journal/Abstract.
- White Paper Presentation.
Medico-Marketing:
- Continuous Medical Education, Physician Desk Reference.
Total 20 hrs. (+ 5 hrs. post-training queries support over TC)
25,000 RS for Indian Students.
30,000 RS for NRI Students.
What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Medical Writing Job : From 20000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Medical Writing : Progressive & Prosperous.
10. Is there any abroad Opportunities For Medical Writing : Yes, with good experience this chance of abroad opportunities through the companies or through
the experience you gained and doing masters would enable more chances of getting good Medical Writing jobs.
HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR)
HEOR is a field of research that uses economic data to evaluate the value of healthcare interventions, including pharmaceuticals. It can be used to determine the cost-effectiveness of treatments by comparing their costs and benefits.
S.No | Session number | Topics to be delivered |
1 | Session – I | Introduction HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR) |
2 | Session – II | Research Methodology and Study Designs |
3 | Session – III | Introduction to Systematic Literature Review (SLR) – Part I |
4 | Session – IV | Key concept and steps involved in SLR – Part II |
5 | Session – V | Critical appraisal (Why/how to perform it and its importance) in SLR |
6 | Session – VI | SLR (Clinical) |
7 | Session – VII | Pharmacoeconomics and Economic Evaluation Methods (EEM) |
8 | Session – VIII | Patient-reported outcomes (PROs) |
9 | Session –IX | Introduction to Health Technology Assessments (HTAs) agencies and its role |
10 | Session – X | Introduction to Bio-statistics |
11 | Session – XI | Key concepts of Bio-statistics in HEOR |
12 | Session – XII | PubMed interface training superficially for how to retrieve the relevant studies |
The consultation fees is INR 15,000 for Weekend Batches only.
The program is covered over a period of 3 months
What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
BASIC TRAINING ON ARGUS OR ANY APPLICATION SETUP
Oracle Argus Training teaches you how to implement, configure, navigate and use Oracle Argus products.
Computer System Validation (CSV) requirement
- User requirement specification
- Vendor assessment
- Change control initiation
- Initial risk assessment
- Validation Plan Design Specification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Validation summary report
- Traceability Matrix
- Impact assessment
Course Duration : 8 to 10 Hours
Batches : Weekdays and Weekend Batch
Weekdays : Monday to Friday
Weekends : Saturday & Sunday
25,000 RS for Indian Students.
30,000 RS for NRI Students.
What is the Qualification for Doing the course:
B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing).
1. What is the Qualification For Doing the course: B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Oracle Argus Database: From 20000 RS per month to 22000 RS/23000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Oracle Argus Database : Progressive & Prosperous.
10. Is there any abroad Opportunities For Oracle Argus Database : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance Jobs.
UNDERSTANDING E2B R2 REPORTS
The E2B (R2) EDI service is intended for use by regulated industries and regulators to report ICSRs relating to medicines and vaccines only. Adverse events that occur during clinical trials may also be reported using the E2B (R2) EDI service.
Module- 1: E2B Introduction
What is E2B?
E2B R2 Structure
Mapping of E2B elements with ICSR data
Module -2: E2B Profile
E2B Profile Introduction
E2B Profile Definition
Module -3: Setting Up Agency for E2B Transmission in Argus Safety
Introduction to ESM Module
E2B Profile configuration
Agency set up
Data flow of ICSR (E2B) report to Agency/Partner
Module –4 : E2B Validations
What are E2B Validations?
E2B Validation set up
Module –5: Assessment
Assessment
Course completion certification
2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)
35,000 RS for Indian Students.
40,000 RS for NRI Students.
What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for E2B(R3) Reporting Job : From 13000 RS per month to 23000 RS/26000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In E2B(R3) Reporting : Progressive & Prosperous.
10. Is there any abroad Opportunities For E2B(R3) Reporting : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good E2B(R3) Reporting jobs.
ARGUS SAFETY DATABASE ESSENTIALS
Argus Safety Essentials covers the basic and advanced concepts of managing drug safety data using the Oracle Argus Safety application. The course starts with an overview of Oracle Argus Safety 8.1.
Pre-req :
Prior knowledge of SQL/PL-SQL
Module -1: Pharmacovigilance
Pharmacovigilance overview
Argus Safety Overview
Module –2: Argus Safety database overview
Argus Safety database structure
Code list tables
Configuration tables
Case Data tables
Expedited Reporting Tables
Periodic Reporting Tables
Module –3: Case Study and Hands On Exercise
Case Study
Hands On Exercise
Assessment
Course Completion Certificate
2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)
40,000 RS for Indian Students.
45,000 RS for NRI Students.
What is the Qualification For Doing the course: B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
1. What is the Qualification For Doing the course: B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Argus Safety : From 55000 RS per month to 65000 RS/70000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Argus Safety : Progressive & Prosperous.
10. Is there any abroad Opportunities For Argus Safety : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Argus Safety Jobs.
PHARMACOVIGILANCE SYSTEM MASTER FILE
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products.
Objectives
- Registration and maintenance
- Summary of the applicant’s pharmacovigilance system
- Location, registration and maintenance
- Transfers of responsibilities for the pharmacovigilance system master file
- The representation of pharmacovigilance systems
- Information to be contained in the pharmacovigilance system master file
- PSMF section on qualified person responsible for pharmacovigilance (QPPV)
- PSMF section on the organisational structure of the marketing authorisation holder
- PSMF section on the sources of safety data
- PSMF section on computerised systems and databases
- PSMF section on pharmacovigilance processes
- PSMF section on pharmacovigilance system performance
- PSMF section on quality system
- Annex to the PSMF
- Change control, logbook, versions and archiving
- Pharmacovigilance system master file presentation
Course Duration : 8 to 10 Hours
Batches : Weekdays and Weekend Batch
Weekdays : Monday to Friday
Weekends : Saturday & Sunday
25,000 RS for Indian Students.
30,000 RS for NRI Students.
What is the Qualification for Doing the course :
B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Pharmacovigilance System Master File: From 25000 RS per month to 30000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Pharmacovigilance System Master File : Progressive & Prosperous.
10. Is there any abroad Opportunities For Pharmacovigilance System Master File: Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance Jobs.
PL/SQL
PL/SQL (Procedural Language/Structured Query Language) is Oracle’s procedural extension for SQL and the Oracle relational database.
1. Introduction to SQL
2. Data Retrieval Techniques
3. Working With DDL, DML, DCL Commands
4. Integrity Constraints
5. Built In Functions
6. Data Aggregation
7. Importance Of JOINS
8. Set Operators And Pseudo Columns.
9. Sub Queries
10. Introduction To PL/SQL
11. Creating And Using Cursors
12. Understanding Exception Handling
13. Creation Of Stored Procedures
14. Creating & Using Functions
15. Creating & Using Packages
16. Triggers In PL/SQL
2 months
10,000 RS for Indian Students.
15,000 RS for NRI Students.
What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for PL/SQL: From 25000 RS per month to 30000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In PL/SQL : Progressive & Prosperous.
10. Is there any abroad Opportunities For PL/SQL: Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good PL/SQL Jobs.