![Page 1: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/1.jpg)
www.diahome.org
![Page 2: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/2.jpg)
Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
www.diahome.org
employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
![Page 3: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/3.jpg)
PharmacovigilanceMetrics Management & Operations
Oversight
www.diahome.org
Mir Imran Ali M.Pharm, M.B.A, CCDM, PMP
Associate Director
Pharmacovigilance Center
Quintiles India - Bangalore
![Page 4: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/4.jpg)
Overview
• Introduction to Pharmacovigilance Operations
• Key Performance Indicators
• Balanced Scorecard
• Dashboard
www.diahome.org
• Dashboard
• Anticipated Challenges
• Ingredients for a successful Metrics
![Page 5: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/5.jpg)
www.diahome.org
![Page 6: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/6.jpg)
Activities in Pharmacovigilance Operations
www.diahome.org
![Page 7: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/7.jpg)
Why Do we need Metrics ?
• To measure the organizational performance
– “You can’t manage something that you can’t
measure”
www.diahome.org
• To facilitate the management to track and analyze
the performance of the business unit
• To ensure managerial effectiveness by providing
access to summarized information on various
performance metrics
![Page 8: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/8.jpg)
Ascertaining KPIs
• Outline the strategy map based on the Balanced
Scorecard Methodology
• Feature four perspectives:
– Finance, Customer, Process and Learning and
www.diahome.org
– Finance, Customer, Process and Learning and
Growth
• Ascertain strategies under each perspective
• Determine a set of measures for each strategy
• Present a drill down of these measures to the
Functional Heads/relevant stakeholders
![Page 9: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/9.jpg)
Balanced Score Card
• BSC is an approach in strategic management developed
in the early 1990's by Dr. Robert Kaplan and Dr. David
Norton
www.diahome.org
• It measures if an organization is meeting its objectives in
terms of vision and strategy
• BSC provides a comprehensive view thereby enabling
the organization to work on their best long term interests
![Page 10: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/10.jpg)
Overview of the Balanced ScorecardOverview of the Balanced Scorecard
Vision
Strategy
www.diahome.org
Strategy
Critical Success Factors
Organizational
Learning
Internal
Business
Process
CustomerFinancial
KPIs
StrategicInitiatives
![Page 11: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/11.jpg)
A BSC Strategy Approach
www.diahome.org
![Page 12: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/12.jpg)
Present it on a Dashboard!
• Once KPIs are in place, create a dashboard containing all the key performance indicators with a snapshot of the defined metrics
• Provide relevant access to key stakeholders which would give the individual a glimpse of the organizational performance across the four perspectives
www.diahome.org
across the four perspectives
– Different level of information will be required for different stakeholders
– This will extend managerial vision provide easy and quick access to summarized information
• Presenting the information on a defined 6 month/12 month rolling period along with coloured (Green, Yellow and Red) indicators will clearly indicate the direction the organization is heading on its various Strategic Objectives
![Page 13: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/13.jpg)
Anticipated Challenges
• Limited automated processes and therefore largely dependant on manual data.
• Extensive involvement required from all stakeholders to define:
– KPIs
www.diahome.org
– KPIs
– Formulas to be used
– Frequency of reporting
– Identification of owners for each metric
• Metrics integrity by automating and validation of all key metrics
![Page 14: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/14.jpg)
Anticipated Challenges contd…
• Working with multiple platforms is challenging
• Operational staff usually focus more on projects
delivery and do not consider providing information
www.diahome.org
delivery and do not consider providing information
for metrics high on their priority list
• Involvement of different support functions such as
Finance, Training, QA and HR adds to the
complexity
![Page 15: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/15.jpg)
Ingredients for a successful Metrics
• Ensure buy-in from Senior Management is involved
• KPIs should be linked to business strategies
• Make it everyone’s job. Align it to performance goals and
incentives
www.diahome.org
• Use it as a tool for:
– Continuous communication on
the Organizational Performance
– Empower the workforce
– Continuous improvement
– Sharing of learnings
![Page 16: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/16.jpg)
Metrics Approach - Dashboard
www.diahome.org
Metric Name
Contract Definition
SLA measure
Criteria
Reporting elements
Formulae
Frequency of metric collection
![Page 17: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/17.jpg)
Success Story……
• In the Quintiles India Data Management group the metrics were driven by a Six Sigma approach where methodologies like BSC and Strategy Map were adopted.
• As a result they were able to:
– Achieve high visibility and acceptance on the importance of metrics
www.diahome.org
– Get buy in from key stake holders
– Make it everyone’s job
– Ensure that the right metrics were monitored/had a plan to be monitored
– See that all metrics had a clear and agreed definition, formula, methodology of data collecting, frequency of reporting etc. and everything was clearly documented.
– Put in place a process to review the metrics on a periodic basis
• Learning from this team was adopted by the Pharmacovigilance Center
![Page 18: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/18.jpg)
Acknowledgements
• Mr. Suresh Ramu Vice President and Regional Head, Asia, CDM
• Mr. Jacques Watson Senior Director and Head of Programming
• Ms. Susan Watson Senior Director, Pharmacovigilance Center
www.diahome.org
• Ms. Susan Watson
• Ms. Nagalakshmi Shetty Manager, Clinical Data Management
• Mr. Rajesh Reddy Operations Scientist
![Page 19: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/19.jpg)
Together we can “Improve Safety Profile, Promote Rational Use”
www.diahome.org
![Page 20: DIA Imran Ali Quintiles Pharmacovigilance.ppt](https://reader031.vdocument.in/reader031/viewer/2022012013/6158599c0005db49271dd084/html5/thumbnails/20.jpg)
www.diahome.org