Online Certificate Courses in Pharmacovigilance
Pharmacovigilance is a critical and evolving field within the healthcare and pharmaceutical industries that focuses on the monitoring, assessment, and prevention of adverse effects or any other drug-related problems. It plays a fundamental role in ensuring the safety and effectiveness of medications for patients worldwide. This introductory overview will provide you with a better understanding of the importance, scope, and key aspects of pharmacovigilance. Best Pharmacovigilance Training Institutes in India at Skill bee Solution is India leading Pharmacovigilance Online Courses with Certificate 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 the ever growing and recession proof CR industry. Only professionally trained employees get to make their mark and reach the pinnacles of success in this fast-moving sector of the healthcare industry. Thus, Skill Bee solution targets to teach Pharmacovigilance Course with Placement, training and polish aspirants as Pharmacovigilance professionals with clear understanding and complete
knowledge of the industry and its working. the Industry Certificate
Programme Pharmacovigilance aims to benefit the professionals working in the various CR industries as it is structured y experts from the industry themselves and so global coverage and understanding of the industry and its functional areas is promised. This Pharmacovigilance Courses 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 reaction can be advantage of Pharmacovigilance is a critical and evolving field within the healthcare and pharmaceutical industries that focuses on the monitoring, assessment, and prevention of adverse effects or any other drug-related problems. This Best Pharmacovigilance Training Institutes in India. It plays a fundamental role in ensuring the safety and effectiveness of medications forpatients worldwide. This introductory overview will provide you with a better understanding of the importance, scope, and key aspects of pharmacovigilance 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. The central concept of Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. We are Providing Pharmacovigilance Online Courses and training with Certificate in UK, USA, Bangalore and Hyderabad.
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.
Key Objectives:
Certified Study Courses
Module 1:Â Introduction to Pharmacology, Clinical Trials and Pharmacovigilance
Module 2:Â Adverse Drug Reactions and Safety Reports
Module 3:Â Methodologies in Pharmacovigilance
Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance (Argus, ArisG, MedWatch, MedRA, WHODD etc.)
Module 5:Â Seriousness & Expectedness & Causality Assessment Criteria
Module 6:Â Aggregate Safety Reports
Module 7:Â Pharmacovigilance Regulations in Various Countries
Module 8:Â Pharmacovigilance Programme in India (PVPI)
Module 9:Â Signal Detection and Data Mining
Module 10:Â Pharmacovigilance of Herbal Drugs & Medical Devices
Module 11:Â Pharmacovigilance Compliance and Inspections
Module 12:Â Hands-on training on Argus, ArisGlobal, ABcube etc software platforms.
Module 13:Â Case Study
Brief of topics to be cover in Training course
1. Â Â Welcome and Introduction, History & Overview of Pharmacovigilance
2. Â Â Drug Development and Clinical Trial Phases
3. Â Â Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.
4. Â Â Pharmacovigilance Process & Life cycle
5. Â Â Introduction and responsibilities: USFDA, EMA and CDSCO
6. Â Â Pharmacovigilance in India
7. Â Â Clinical Development process
8. Â Â Different phases of clinical Trials
9. Â Â 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:
Case processing
MeDRA coding & WHO DD coding
Duplicate Check and case initiation
SAE Narrative writing
Benefits of Courses from Skillbee Solution
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.
Eligibility
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 Certification in Pharmacovigilance.
Upon Successful completion of Course our team will provide Following
Resume PreparationÂ
Interview Preparation and Mock Interview Session.
Communication skills and personality development sessions
Placement Assistance
Registration
The registration will be carried out by contacting on Skillbee Solution. How To Apply
Programme Deliverables
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.
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Assignments for all the programme modules for continuous evaluation and guidance.
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Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
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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.
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All the efforts are made by faculty members to make the entire programme modules easily understandable.
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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.
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At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
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All learning and training delivery initiatives shall be conducted in English.
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Certification and Membership Fees
- Contact on +91-9691633901, +91-8839538846 or info@Skillbee.co.in for details of Pharmacovigilance Course Online fees structure
Assessment & Certification
- Pharmacovigilance Course with Placement to participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by skill bee solution.
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.Â
In recent months the Institute has witnessed more and Providing Training And Courses in Bangalore, Hyderabad, UK and USA 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.