Best Pharmacovigilance Training Institutes in India
Company Connect Consultancy
Clinical research is a branch of healthcare science which includes detailed study of human health and study. It focuses to advance medical knowledge by studying candidates through direct interaction or through the collection and analysis of blood, cell, tissues or some other samples.
Qualified Pharmacovigilance Professional training course aim to create Pharmacovigilance professionals by covering all the technical aspects of Pharmacovigilance job. The program includes 12 weeks of extensive training incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training on case processing with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing.
Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals and news. Medical writing can be classified into two types: Regulatory medical writing and Educational medical writing.
Online Certificate Courses in Pharmacovigilance
Company Connect Consultancy is India’s leading Pharmacovigilance Course Training Institute based in Hyderabad, Bangalore, Pune and Mumbai. Those who are seeking a role in drug safety or pharmacovigilance should hold a life sciences, pharmacy or medical degree.
Pharmacovigilance is an inseparable part of ever growing and recession proof CR industry. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus Company Connect Consultancy targets to teach, train and polish aspirants as Pharmacovigilance professionals with clear understanding and complete knowledge of the industry and its working.
The Industry Certificate Programme in Pharmacovigilance aims to benefit the professionals working in the various CR industries as it is structured by experts from the industry themselves and so global coverage and understanding of the industry and its functional areas is promised.
This course covers a variety of important aspects of the career, including reporting, report writing, signal detection and risk management, as well as providing a thorough understanding of the regulatory bodies around the world.
For anyone looking to find a job in pharmacovigilance or drug safety, previous experience in the industry is of great value. Alternatively, a clinical background and first-hand experience with adverse reactions can be advantageous so nurses and pharmacists can also be attractive candidates.
A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance.
Finding a pharmacovigilance job or drug safety position abroad can also be a great opportunity for those seeking a career in this sector and opportunities are prevalent, although generally in the larger companies.
Remuneration for a position in drug safety and pharmacovigilance can vary greatly, with factors including the company, the location, the candidate’s experience and the requirements of the role.
What jobs are available in drug safety and pharmacovigilance?
Jobs in drug safety and pharmacovigilance exist in both permanent and contract arrangements. Temporary agreements can last from three to 12 months, with many of these positions being for drug safety medical writers or interim pharmacovigilance physicians.
Drug safety associates and officers monitor and track adverse events and reactions, as well as other medically related product information.
Senior pharmacovigilance consultants process adverse event reports sourced from various studies. The information that is gathered is then submitted to the regulatory authorities.
Drug safety managers and directors organise the processing and reporting on drug safety reports and review trial-related documents in order to monitor the drug safety profile of specific products. Responsible for medical case reviews and assessing product safety in clinical trials, drug safety physicians work to assess and obtain information about the safety of products.
Certified Study Courses
Module 1: Introduction to Pharmacology, Clinical Trials and Pharmacovigilance
Module 2: Adverse Drug Reactions and Safety Reports
Module 3: Methodologies in Pharmacovigilance
Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance (Argus, ArisG, MedWatch, MedRA, WHODD etc.)
Module 5: Seriousness & Expectedness & Causality Assessment Criteria
Module 6: Aggregate Safety Reports
Module 7: Pharmacovigilance Regulations in Various Countries
Module 8: Pharmacovigilance Programme in India (PVPI)
Module 9: Signal Detection and Data Mining
Module 10: Pharmacovigilance of Herbal Drugs & Medical Devices
Module 11: Pharmacovigilance Compliance and Inspections
Module 12: Hands-on training on Argus, ArisGlobal, ABcube etc software platforms.
Module 13: Case Study
Brief of topics to be cover in Training course
1. Welcome and Introduction, History & Overview of Pharmacovigilance
2. Drug Development and Clinical Trial Phases
3. Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.
4. Pharmacovigilance Process & Life cycle
5. Introduction and responsibilities: USFDA, EMA and CDSCO
6. Pharmacovigilance in India
7. Clinical Development process
8. Different phases of clinical Trials
9. Adverse events and its types
10. Drug Safety in clinical trials and post marketed drugs
11. Different sources of Adverse events reporting
12. Different types of AE reporting Forms
13. Expedited reporting and its timelines
14. Different departments working on Pharmacovigilance
15. Roles and responsibilities of case receipt unit
16. Roles and responsibilities of Triage unit
17. Four factors for the reportable case
18. Seriousness criteria of adverse event
19. Expectedness or Listedness of adverse event
20. Causality assessment of the adverse event
21. Introduction to safety database and different types
22. Narrative writing
23. Case quality check, Medical review and its submission.
24. The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
25. PSUR and its submission timelines
26. Regulatory Authority in Pharmacovigilance
27. ICH GCP Guideline
Practical Training will be also provided on Oracle Argus Safety Database on the following topics:
MeDRA coding & WHO DD coding
Duplicate Check and case initiation
SAE Narrative writing
Benefits of Courses from Company Connect Consultancy
Complete Course Material will be provided including detailed information about the entire work flow of Drug Safety Associate.
2 months internship available after rigorous training in Pharmacovigilance.
Own CRO live Projects
We Provide Real Time Experience on Global Drug Safety Software with PSUR & DSUR Training.
Highest Placement record across all training institutes
Industry based SOP’s training
Trainers with minimum of 7+ years of experience
Comprehensive teaching by Medical Doctors
Hands on experience on Global Safety Databases used in the Industry.
Total 150 hours of exposure to theory, case studies and practicals.
Practical Hands on Training will be provided on Case Processing, Narrative Writing, MedDRA 16.1 & Who DRUG Coding.
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
Upon Successful completion of Course our team will provide Following
Interview Preparation and Mock Interview Session.
Communication skills and personality development sessions
The registration will be carried out by contacting on Company Connect Consultancy. How to Apply
A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
Assignments for all the programme modules for continuous evaluation and guidance.
Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.
All the efforts are made by faculty members to make the entire programme modules easily understandable.
Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
All learning and training delivery initiatives shall be conducted in English.
Certification and Membership Fees
Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure
Assessment & Certification
All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Company Connect.
Placement Assistance & Corporate Relations
The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.