- Drug Safety Monitoring activity includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies. Surveillance of medicine safety is an essential and critical activity for Pharmaceutical Companies who have invested billions in the drug development process so that their drug is successful in the market. World Health Organization aims to assure the safety of medicines and vaccines by ensuring the reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization, and encouraging participation in the WHO Program for International Drug Monitoring. So, therefore there is an ongoing demand for skilled Pharmacovigilance Professionals in the Industry.
Needless to say, every organization is skeptical about choosing the right candidates possessing not only knowledge, and skills but to some extent experience in handling Pharmacovigilance activities so minimal training is required for them. Given this ongoing requirement both from the industry and from the candidates, Sparkling CliniTech is introducing this Pharmacovigilance Project Work that is performed in the industry. This will help candidates to understand the technicality of work and also gain hands-on experience from the Industry Professional. The program will enrich the candidates with working experience that will be much preferred in the industry.
Live Classes
Interactive video lessons
Duration of the Program:
1 Month (Candidates with Pharmacovigilance Knowledge/background/course)
2 Months (Candidates without Pharmacovigilance Knowledge. In this Pharmacovigilance theoretical course will be completed in the first month and the project can be done in the second month)
Eligibility:
Medicine, Dental, Nursing, Pharma, Life Science Candidates (Student, Fresher, or Professionals working in other domains)
Skills Required:
Ability to handle computer/laptop
Knowledge of Microsoft Office Usage
Pharmacovigilance Theoretical Knowledge
MedDRA knowledge
Project Guide Information:
PV Professional with 15 years of Industry Experience
Conducted the project & triage analysis for 10 years
Domain Specialist in Coding, Narrative writing & Case Analysis
Experience in Project Guidance for M.S Students from Reputed University
Project Details:
Do you know how analysis for USA’s biggest poison control cases is performed in Industry? If you have the skills, and interest and are ready to take up the challenge of solving it accurately alongside how exactly an experienced industry person performs it, then this program is ideal for you.
Project Title:
Retrospective analysis of the previous year’s poison exposures and emerging public health hazards.
Project Details:
USA’s real-time poisoning data surveillance system will be used for the Detection, Assessment, and Understanding of the products that have acted as poison and resulted in death cases. The same process is followed in the industry every year when the data is released by the poison control center. Manufacturers responsible for their products use the same source information to perform effective Pharmacovigilance activities and meet the regulatory requirement. As part of this project activity, candidates will get exposed to real-time Pharmacovigilance surveillance activities that happen in Industry. The project will be completed and guided under Pharmacovigilance Industry Professional so that students can clarify all the queries during the activities and get exposed to real-time challenges and solutions.
What can you expect:
Part A: Technical Experience
Understanding Pharmacovigilance from core
Identification of the poison control article with literature surveillance
Review the process of the articles & Understanding of Table 21
Triage of all the products & ICSR Cases listed in table 21
Preparation of the Assessment Tracker
Accurate Reportability Assessment for Each Case
Full data entry of all relevant information from the source data in the tracker
Manual coding of all adverse events terms using the latest MedDRA Dictionary, hands-on dictionary access
Complete narratives for ICSRs based on article information
Reconciliation & Review of the completed Work
Preparation of Pharmacovigilance Safety Report and Signal Identification
Part B: Organizational Experience
Systematic Review and analysis of skill development
Triage Tracker Maintenance
Time management skill development
Completion of assessment within the stipulated timeline
About Course Creator
Mayuri Roy – Director of Sparkling clinitech
- Experienced Pharmacovigilance Mentor
- Masters
- 15 yrs Experience
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