About Us


Education is the foundation upon

which we build our future.

Our teaching faculty is Pharmacovigilance, Medical Writing. Computer System Validation and Argus Administrators Industry Experts with 12 Plus Years of extensive experience. Expertise in Career consultation & Counseled more than 700 plus life science students. We offer the best and cost effective courses, with out any compromise on quality of education. Placed more than 122 Candidates (Both Fresher’s & Experienced) till date.

Courses

PHARMACOVIGILANCE


Pharmacovigilance Course Contents :

Introduction to Pharmacovigilance (PV) Basics & Course curriculum.
Drug development.
PV Career scope & PV Companies in India.
PV Terminologies & Glossary.
PV Websites.
MedDRA Coding.

ICH Guidelines (E2A to E2F).
GVP Modules (1 to 16 Modules).
Causality Assessment.
Safety Narrative Writing (3 Types of Narratives, Spontaneous, Clinical Trial & Literature).
Training on PV Database, PV Work Flows & Different software’s in PV Industry.
Vaccine Pharmacovigilance.
Materiovigilance (Medical Device).

MEDICAL WRITING


Medical Writing Course Contents :
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.

COMPUTERIZED SYSTEM VALIDATION


Computer system Validation Course Contents:
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.

Take Back to Your Job:
Interpret the 21 CFR Part 11 regulation.
Understand Part 11 key issues and be prepared for Part 11 inspections.
Apply GAMP risk management approach for Part 11 compliance.
Discuss international regulatory expectations for use and control of electronic records and signatures in computer systems used in the pharmaceutical and related life sciences industries.
Workshop series featuring half day sessions on.
Documentation for demonstrating.
Data Integrity.
Audit Trails.
Vendor Assessment & Qualification.
Writing a URS.
Backup procedures.
Validate your systems to ensure accuracy, reliability, consistent performance and data integrity.

ARGUS SAFETY FOR ADMINISTRATORS - Total 20 hrs. (+ 5 hrs. post-training queries support over TC)


Course Introduction and High-level Overview of Argus Safety :

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.

CLINICAL DATA MANAGEMENT


Clinical Data Management Course contents :

Module – 1: Introduction to Clinical Research and Clinical Data Management
Roles & Responsibilities of Key Stakeholders.
Standard Operating Procedures.
Study Set-up Phase :
Module – 2: Creation of Study set-up documents
Protocol Orientation.
Preparation of DMP/DHP.
CRF Design.
Preparation of DVP.
CRF Annotation.
DB-Design and Set-up.
User acceptance test.
Third party data specifications and testing.
Coding Specifications and testing.
SAE Reconciliation specifications.
Self Evident Correction specifications.
Custom reports specifications.

Study Conduct phase :
Module – 3: Study Ongoing phaset
Tracking CRF Data.
Data Entry, Remote Data Entry.
Data review and query management.
Managing Lab Data.
Medical Coding.
SAE Reconciliation.
Post-Production Change management (PPC).
Self Evident Correction Management (SEC).
Creating Reports .
Study Close-out phase :
Module – 4: Study Close out phase
DB listings QC as per QC plan.
Track all data as per DB Lock checklist.
Final DB QC.
Data Base Lock.
Data Base archival and study data transfer.
Module – 5: Case Studies

CLINICAL RESEARCH


Clinical Research Course Contents :

Introduction to CR - 2 hrs
a) Definitions and types of CR.
b) Overview of CR processes.
c) Opportunities in CR.
d) Career Development in CR.
BA/BE studies-Clinical and Regulatory procedures-ANDA-21 CFR 320 - 4 hrs
CRO-Organization, Structure, Role, Responsibilities, Costing - 4 hrs
Contracts and Agreements—CDA, MSA, CTA - 2 hrs
Insurance and Indemnity - 1 hr
Overview of SOPs/Study Plans - 2 hrs
Overview of Protocol, ICF, IB, AEs - 3 hrs
Responsibilities: Sponsor/Investigator/EC - 4 hrs
Phases of Clinical Trials - 2 hrs
Clinical Trial Management-ICH GCP - 4 hrs

Clinical Trial Procedures:
Budgeting, Medical Writing, IM, SIV, SMV, SCV - 4 hrs.
CT-Regulatory- Indian Forms as per CDSCO-# 44, 45, 12, 11 - 2 hrs
US-Forms-1571, 1572, 3454, 3455 - 2 hrs
CT-Regulatory Procedures-India-Schedule Y - 4 hrs
US-21 CFR part 50, 54, 56, 312, 314 - 4 hrs
EU-EMEA, Australia-TGA, UK-MHRA, Canada-HPFB, Japan - 4 hrs
All CR related Forms-AE, SAE, Subject ID code list, Staff Delegation log, etc - 4 hrs
Audits and Inspections: Overview-Quality systems and SOPs - 2 hrs
Audits and Inspections: Overview-Quality systems and SOPs - 4 hrs
Medical Devices-PMA, similarities and differences between Medical Devices and Drugs - 2 hrs

Why Should you join Rise Trainings ?

We are experts in bridging academic excellence and industry expertise and expectations.
Intensive training on Pharmacovigilance/Medical Coding/Regulatory Affairs by experts.
Our trainers team accelerates life science graduates job search by transforming (C2C) College student to Corporate trainee and professional.
Free Soft skills training.
Free Resume Preparation.
100 % Placement Assurance.

Services

  • Trainings

Workshops / Weekend Crash Courses would be conducted based on demand. Online Trainings-2-3 Students enrollments. Campus Trainings-10 Students minimum enrollment required, to be carried out by Understanding and requirements from the placements and training officers request.

  • Resume Services

We do assist your job search by highlighting your skillset and strengths. Our Resume preperation team offers you excellent resume services. For Interview winning resumes reach out us at risetrainings@outlook.com

  • Placements

We do offer placements assistance for our students as a free of cost and as a part of our training programme. Charges are additional for candidates who were not trained from RISE TRAININGS. Do reach us to expedite your job search and placement assistance. We have successfully placed 122 candidates, both Freshers and Experienced till date.



Testimonials

Students Testimonials

Indu. K, Pharm.D, Medical Services Associate, Accenture, Chennai

My training at Rise Trainings was full of learning with extreme knowledge. The quality of lecturers was beyond my expectations and they represented great blend of all modules in pharmacovigilance. The coaching Insitute has given me a lot of confidence. I have learned so much through the Institute. I found it is first stepping stone for success in my professional career. So I thank you with all my heart for helping me find my career in my life.

Lakshmi Lahari. K, Pharm.D, Drug Safety Associate, Bioclinica, Mysore

Excellent coaching centre for pharmacovigilance aspirants with good teaching skills and it is very economical. In addition, trains in communication skills and provides good support to our career.

Ramya. G, B.pharmacy, Medical Services Associate, Accenture, Chennai

Starting new phase of life is never easy. They have many unknown challenges and many obstacles that come our way and without experience. As I have faced many interviews. The exposure I have on various aspects got to know that the private sector requires references even if we have better knowledge. Then I came to know about ‘RISE TRAININGS’. They had given training in pharmacovigilance and ends up with giving a placement in Jeevan Scientifics, Hyderabad which is the best company to earn working skills and knowledge.


SaiNaveen. S, Pharm.D, Trainee, Drug Safety Symbiance , Chennai

I immensely thank the Risetrainings for providing the Pharmacovigilance Training & Internship training program which helped me groom and prepare myself for the challenges in the industries. The Faculty and staff are all dedicated to student success and innovation, making Risetrainings Academy an exciting place to learn. The flexible and professional environment for learning provides the opportunity to explore yourself and make you a corporate professional.

Haritha. N, Medical Services Associate, Accenture, Chennai

Thanks for arranging such an effective and good training program for us and this will remain the pioneer of training programme in and around Nellore district. The staff all are well educated, trained and also dedicated to their profession. They are very interactive and share their valuable ideas and information for our bright future. They have always been prompt in responding to our needs. The Trainer’s delivery of sessions, methodology adopted for training, Training materials provided as course material was in line with our expectations.

Sravani. G, Pharm.D, Trainee, Drug Safety Symbiance , Chennai

It is with great pleasure I am writing this testimonial for rise trainings. Institution is absolutely amazing and very helpful with getting me a job. I had a highly pleasant and positive experience through out our colloboaration. Rest assured that faculty efficience and guidance will help other candidates to find employment. Finally I would highly recommend risetrainings if you are looking for you next opportunity. Thank you risetrainings for all your support.


Nuthana Deepthi. K, Drug Safety Associate, PharmaConsul, Hyderabad

I am very happy to share this news about my career success with the support and help of RISE TRAININGS. And i learned many things in training period the most important thing was communication. Even if you are good at studies you need to communicate all to grow in the Pharmacovigilance sector. I strongly recommend Rise Trainings to Pharmacy graduates for their Trainings and Job Consultation services.

Srilekha. G, Member Technical Staff, Hcl Technologies, Madhurai

I really like the placement process of Rise Trainings institution, everyone is working really hard for all students success. So that they could get easily placed in best companies, I was really lucky that I got placed in HCL company because of rise training institution. I'm always thankful to Rise Trainnigs team and pradeep sir for your valuable support for my placement assistance.