XERTZ Solutions a Pharmacovigilance Training and Placement group located in Chennai. The trainers are full time PV Specialists, who have handled multiple projects for Accenture, PAREXEL, ICON, etc. with an average experience of 6 years. Recently trained 12 of its trainees are placed successfully in Corporate like Quintiles, Accenture, Synowledge, etc. So, if anybody want to pursue their career in PV, please contact XERTZ without hesitation. Thank you
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XERTZ Pharmacovigilance Career Development program and Job
1. Excellence In Pharmacovigilance
Xertz Solutions, #107B, L.D.G Road, Little Mount, Saidapet, Chennai – 600 015, INDIA. support@xertzsolutions.com +91 44 6555 7787
2. Scope
O Who we are?
O What we do?
O The Industry
O Why we are here?
O Why Xertz?
O Thanks note
3. Xertz providing Medical Coding consultancy services from the
year 2007, and established further in 2013 to provide wide
range of services for Healthcare, Bio-Tech & Pharmaceutical
Industries.
Xertz provides Professionally managed Career Development
and Placement services in the areas of
* Pharmacovigilance/Drug Safety
* Clinical Research & Clinical Data Management
* Medical Coding & Medical Billing
confidential
4. We deliver the services with highest
Quality in shortest Timeline, as expected by our
valuable Customers (Corporates and Individuals).
Vision:
To become No. 1 Training and Placement
Partner for Healthcare, Bio-Tech and
Pharmaceutical Organizations in India.
Mission:
confidential
5. Services
• Pharmacovigilance CDP
Our
Pharmacovigilance Internship Program
Services
Pharmacovigilance Certification Program
Pharmacovigilance Training & Placement
confidential
6. Glimpse of Our Program
• Individual Case Safety Reports (ICSR)
• literature monitoring to identify
adverse events and safety data
• PV Workflow and Case Processing in
ARISg and ARGUS Safety
• Aggregate Reporting
• MedDRA and WHO DD Coding
• Signal detection and evaluation
• Time to Onset, Action taken, Dechallenge
and Rechallenge
• Risk management plan
• Follow-Up and Query Handling
• Seriousness, Causality and Labeling
assessments
• Reference Safety Information
• Narrative writing
• Quality management system
• Medical Review and MAH Comment
• Pharmacovigilance Industry and your
Job role
• Assessment on expedited and electronic
reporting of ICSR for authorized
medicinal products
• Pharmacovigilance & Medical Affairs
7. Different Roles in PV Projects
Triage and Case
Reporting
• Case Validation,
Prioritization, Book
in, Routing and
Tracking Case
Reporting
(E2B/Paper mail)
Quality Review /
Safety Review
• Review - Post triage,
Post Data processing,
Post Medical review,
Post Reporting
Aggregate
Reporting
Data Processing
and Coding
• Preparation and
submission of
periodic and other
reports from ICSRs
• Duplicate check,
Case processing,
MedDRA & WHO-DD
Coding, narrative
writing
• Coding review,
Assessments
(Suspectedness and
Listedness), narrative
review and Medical
Writing
Project
Management
Database
Administration
Biostatistics
• Data Mining and
Extraction, Report
generation and
Signal Detection
Medical Review
• Initiate, Execute,
monitor all project
related activities
confidential
• Customizing
Databases, Technical
Support and
maintenance
8. Our Support to Graduated Individuals
Certified Pharmacovigilance Professional
• 160 hours of Participation (8 weeks to 12 weeks, per requisite)
• Training, Mentoring and Project work in Pharmacovigilance Database
• Review, Feedback, Assessment and Certification
• Nominal and Flexible Fee structure (includes Snacks)
• Accommodation and Food arrangement, if required
• Eligibility: B. Pharm, M.Pharm (any) and Pharm.D
Note: Week-end batches are available for working Professionals
confidential
10. Highlights of XERTZ’S Career Development
6 years of average trainers’ experience with managerial exposure
Career Counselling in Employer’s view, and addresses
Industry and Organization structure Overview
Employment & Employer Expectations
Project/Client Agreements
Lean Operational Management
Leadership and People Management
Key to success or how to become a performer?
Performance management and annual review
Rewards and Recognitions