- 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
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.
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.
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.
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