Xertz Solutions, #107B, L.D.G Road, Little Mount, Saidapet, Chennai – 600 015, INDIA. [email protected] +91 44 6555 7787
Excellence In Pharmacovigilance
Scope
O Who we are?
O What we do?
O The Industry
O Why we are here?
O Why Xertz?
O Thanks note
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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
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Vision: We deliver the services with highest Quality in shortest Timeline, as expected by our valuable Customers (Corporates and Individuals).
Mission: To become No. 1 Training and Placement Partner for Healthcare, Bio-Tech and Pharmaceutical Organizations in India.
•Pharmacovigilance CDP Pharmacovigilance Internship Program Pharmacovigilance Certification Program Pharmacovigilance Training & Placement
Services
Our Services
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• Individual Case Safety Reports (ICSR)
• PV Workflow and Case Processing in ARISg and ARGUS Safety
• MedDRA and WHO DD Coding
• Time to Onset, Action taken, Dechallenge
and Rechallenge • Seriousness, Causality and Labeling
assessments
• Narrative writing
• Medical Review and MAH Comment
• Assessment on expedited and electronic reporting of ICSR for authorized medicinal products
Glimpse of Our Program
• literature monitoring to identify adverse events and safety data
• Aggregate Reporting
• Signal detection and evaluation • Risk management plan
• Follow-Up and Query Handling
• Reference Safety Information • Quality management system • Pharmacovigilance Industry and your
Job role
• Pharmacovigilance & Medical Affairs
Triage and Case Reporting
• Case Validation, Prioritization, Book in, Routing and Tracking Case Reporting (E2B/Paper mail)
Aggregate Reporting
• Preparation and submission of periodic and other reports from ICSRs
Data Processing and Coding
• Duplicate check, Case processing, MedDRA & WHO-DD Coding, narrative writing
Medical Review
• Coding review, Assessments (Suspectedness and Listedness), narrative review and Medical Writing
Quality Review / Safety Review
•Review - Post triage, Post Data processing, Post Medical review, Post Reporting
Biostatistics
• Data Mining and Extraction, Report generation and Signal Detection
Project Management
• Initiate, Execute, monitor all project related activities
Database Administration
• Customizing Databases, Technical Support and maintenance
Different Roles in PV Projects
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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
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Our Support to Graduated Individuals
Note: Week-end batches are available for working Professionals
Our Potential Clients
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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
Why XERTZ?
Individual Attention
Affordable Fee
Structure
Mock projects
and Feedback
Trainer’s Vast
Experience
Empathetic Approach
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Contact Us
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XERTZ Solutions
#107-B, L.D.G Road,
Little Mount,
Saidapet,
Chennai – 600 015
Tamilnadu, INDIA
Phone: + +91 44 6555 7787
Email: [email protected]
www.xertzsolutions.com
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