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Excellence In Pharmacovigilance

Xertz Solutions, #107B, L.D.G Road, Little Mount, Saidapet, Chennai – 600 015, INDIA. support@xertzsolutions.com +91 44 6555 7787
Scope
O Who we are?
O What we do?
O The Industry
O Why we are here?
O Why Xertz?
O Thanks note
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
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
Services

• Pharmacovigilance CDP
Our
 Pharmacovigilance Internship Program
Services

 Pharmacovigilance Certification Program
 Pharmacovigilance Training & Placement

confidential
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
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
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
Our Potential Clients

confidential
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?

Mock
projects
and
Feedback

Empathetic
Approach

Affordable
Fee
Structure

Trainer’s
Vast
Experience
Individual
Attention

confidential
Contact Us

XERTZ Solutions
#107-B, L.D.G Road,
Little Mount,
Saidapet,
Chennai – 600 015
Tamilnadu, INDIA
Phone: + +91 44 6555 7787
Email: support@xertzsolutions.com
www.xertzsolutions.com

confidential
confidential

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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
  • 12. Contact Us XERTZ Solutions #107-B, L.D.G Road, Little Mount, Saidapet, Chennai – 600 015 Tamilnadu, INDIA Phone: + +91 44 6555 7787 Email: support@xertzsolutions.com www.xertzsolutions.com confidential