Drug safety or Pharmacovigilance is in the spotlight of new drug development. This carves a vital niche inside the expanding pharmaceutical business. It would be apt to say that as much as pharmaceutical business is evergreen, the pharmacovigilance is ever greener.
In the USA the total cost incurred due to medication errors or adverse drug reactions (ADRs) exceed 136 billion USD annually and hence, the regulatory agencies worldwide have developed stringent guidelines for drug approvals as well as for continuous monitoring of drugs in clinical practice.
The World Health Organization (WHO) has defined pharmacovigilance as the science and all the associated activities related to the detection, evaluation, understanding and prevention of ADRs or any other drug-related problems. ADRs (especially the serious drug reactions or SAEs), medication and prescription errors and poor drug qualities are the major concerns which are dealt with by pharmacovigilance systems. Thus, risk management, risk mitigation plans and discovery of safety signals from data mining of existing safety databases are immensely important activities during the development as well as post marketing phases in the life cycle of a drug. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries and many pharmacovigilance centers are working for drug safety monitoring in this global pitch.
A very important constituent of a compliant pharmacovigilance program is to maintain large safety databases. Such requirements of maintaining and analyzing extremely large quantities of data has pushed pharmaceutical companies to outsource pharmacovigilance data management and analysis to cost effective hubs like India, Philippines, China, to name a few major ones. It is pertinent to note that the outsourced pharmacovigilance activity to India is on a steep rise for last 5 years. With the heavy outsourcing comes the need of trained professionals, and so XCEL CAREER
Objective of Pharmacovigilance
- Proactive monitoring and reporting on the quality, safety and efficacy of drugs,
- Assessment of the risks and benefits of marketed medicines,
- Monitoring the impact of any corrective actions taken,
- Providing information to consumers, practitioners and regulators on the effective use of drugs,
- Designing programs and procedures for collecting and analysing reports from health care professionals (HCPs), patients, relatives, lawyers, journalists etc.
- Early detection of unknown/unexpected safety problems,
- Detection of increases in frequency of Adverse Drug Reactions (ADRs) to a drug, in patients/subjects treated with this medication,
- Identification of risk factors for ADRs,
- Risks Analysis Mitigation,
- Benefit-Risk balance.
Pharmacovigilance Module overview
- Introduction to PV
- Process of PV
- The PV Jargons
- GVP
- Narrative Writing
- A. E. Reporting
- Pharmacovigilance in India
- Medical Coding
- XCEL CAREER Professional Education has been constituted to undone the existing vacuum of quality trained resources/Professionals by being a pivotal link between Aspirant and Industry. Here are some of the salient Futures of Xcel Career:
- Core Industry Experience:
XCEL CAREER Institute has close to 20 years of combined experience of Pharmaceuticals, Healthcare with coaching and mentoring experience. Benefit for the student is that they get the most appropriate career guidance to be successful in his pursuit of career/job.
- Producing Multi Skilled Professional’s
The most promising and success clinching element for Xcel career students is that it inculcates the multi-skill learnings. Benefit for the student is that the prospect of getting a job is doubled with this approach.
- Industry Expert Trainers:
Xcel career Institute strong reason for successful existence is based on Expert trainers from Industry. The core benefit for the student is that they gain the Technical knowledge and practical knowledge from the authorities of the subject.
- Curriculum:
Curriculum developed by the XCEL CAREER is a world class keeping in view of Industry current trends and needs. The programs we offer are designed by our team of Industry experts based on the global and Indian Industry requirement. Benefit for the student is that there is no big learning curve is required to master the subject.
- On Job Practical Trainings:
On Job Training is delivered by XCEL CAREER to students and help them develop Industry ready practical skills. Benefit for the students is that it fastens ups getting good jobs.
- Cost Effectiveness:
Cost Effectiveness without compromising on the quality is our main aim which benefits our students with a global expertise and world-class knowledge in the most cost effective manner.
- Training Methodology:
Xcel career courses are most compelling wherein classes are conducted in the conductive, engaging and interactive manner. Students indirectly get enriched everyday with new concepts there by having them ready every day for the Industry opportunities.
- Communication Life Skills Training:
“Your skills, not degree, will get you a job” knowing this fact xcel career puts greater emphasis also on providing finishing school learnings. Students will be enhanced their Resumes development, cover letters, email writing, telephonic Interview, Group discussions, JAM session, Mock Interviews and Many more skill enhanced drills will be conducted during the program.
- Class Size:
Our classes are designed in such way that the lecturers know the students by name. Class size is 8-10 students, hence students benefit in personalised training approach to yield greater results.
- Study Materials:
Free study materials supported with PPT’s, notes, handouts, soft copies, FAQ’s etc. Students can focus on what to study and benefit with ease.
- 100% Placement support:
And XCEL CREER dedicated placement cell for unearthing the remotest of opening details for a maximum of Interview opportunities. Thereby student benefit out of placement support till the time they get employed.