Uploaded byTimothy Roe
Pharmacovigilance Surge Resource Calculator
The document provides an overview of a pharmacovigilance resource calculator tool. It describes the objective of the tool is to help plan optimized staffing levels, especially during surges. It outlines the typical process for building the calculator which includes collecting workflow data, analyzing activities, documenting processes, and testing the calculator output. The tool's interface includes sections for inputting volume and staffing data and outputting budgeted, utilized, and optimized full-time employees and required staffing changes.
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Pharmacovigilance Surge Resource Calculator
- 1. Pharmacovigilance (Europe) Resource Calculator Overview Life Sciences Consulting Confidential Timothy Roe, AVP Client 860-829-6699 -1-
- 2. Contents • About Us • Objective Of the Tool • About the Project • Collection Methods & Analytical Tools • The Subtleties Between EMEA Offices • Building The Calculator • Using the Calculator • Support Assets -2-
- 3. Confidential Co. CorePV Specialties Long Global History With JnJ & Janssen Site Optimization Social Network AE Monitoring and Resource Planning Reporting Integrated Alliance Process Management (iAM) Automation BPO Capabilities -3-
- 4. Typical Pharmacovigilance Process Review Commercia l Status Amended Spontaneous Social Rx Info Reports Networks & Licensing Literature Partners Submissio Reports n Clinical Data Trial Data Review Product Complaints & LOE Licensing Inquiry Worldwide Partners & Respons Regulatory Signal Alliances e Reports Detectio n INTAKE COLLATE & & COLLECTION TRANSLAT ANALYZE COMMUNICATE E -4-
- 5. Objective Of TheTool To help Drug Safety and Surveillance executives plan and manage optimized staffing levels especially during surge events and other crisis situations. -5-
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- 7. Client Enablers 1 2 3 4 5 Provide client Enable client with an to accurately Client has the Client has the analysis of predict surge ability to print ability to Provide their current staffing levels colorized utilize rapid knowledge processes, and at a budgeted, reports for “Rule of transfer and a modeling utilized and immediate Thumb” transparency tool for optimized insertion into calculations of solution to “What-If” and level as well as executive-level outside of the the client. “2B” the change in presentations. tool. scenarios. FTE required. -7-
- 8. Challenges Overcoming the natural protective barriers put forth by internal staff whenever efficiency projects are commenced Gaining a firm understanding of the EMEA business model and various process flows Documenting comprehensive multi-tier (and inter-related) paper-based workflow processes Coding the calculator based on client input and diverse business environments Slight language barriers were easily overcome -8-
- 9. Typical Top-Line SolutionSteps 1. Provide initial data collection tools including forms and templates 2. Perform staff interviews, time studies and volume assessments 3. Document start to end case process flow pre-optimization 4. Perform identification, organization and documentation of the SIPOC (Sources, Inputs, Processes, Outputs and Customers) 5. Analyze activities, data and document findings 6. Organize data into work streams and determine direct vs. indirect time for any FTE processing cases 7. Build the Resource Calculator 8. Test and confirm output. Run against the simulation tool to “tune” the calculator 9. Provide “Rule of Thumb” and polynomial prediction formula’s for rapid Volume/FTE calculation without tool 10. Perform walkthrough of the simulator results and operation of the calculator with client staff -9-
- 10. Collection Methods &Analytical Tools - 10 -
- 11. Typical Assessment Schedule - 11 -
- 12. Documents Inventory - 12 -
- 13. Collected Workflows With WorkshopModifications - 13 -
- 14. Creation Of AnEmployee/Position Matrix For Budgeted And Utilized FTE Calculations Graphical Distribution - 14 -
- 15. SIPOC Details Collected, VerifiedAnd Confirmed - 15 -
- 16. Client Confirmation Sheets ForConsolidated Activities - 16 -
- 17. The Subtleties BetweenEMEA Offices Studied - 17 -
- 18. Analysis of IndividualOffice Processing Activities Steps - 18 -
- 19. Analysis Of IndirectTime Differences Process Indirect Work • 12 Unique Categories – Serbia 8 – NEWAAT 2 – Germany 1 – Ukraine 1 – Time Range 0.1 hr to 4.0 hrs. PV Agreements And Inefficient Office Setup Accounted For The Largest Indirect Time • Consistent Categories Value Ranges Audit N, S Time Range Compliance Check N, S, U Low 0.05 hr Serbia - SPC Checks Inefficient Office Setup N, S High 8.0 hr Serbia - PV Agreements Literature Search & Reviews S, U Other Projects N, S, U Next Top 3 PV Agreements N, S 7.5 hrs NEWAAT - Other Projects Ad Hoc Queries N, S 5.0 hrs NEWAAT - Other Projects NPP, Clin Trials Reconciliations N, S, U 4.0 hrs NEWAAT - Inefficient Office Reporting - Other N, S, U 4.0 hrs NEWAAT - PV Agreements SOP Review & Management G, N, S Note: Hours per Week - 19 -
- 20. Analysis Of IndirectTime Differences People-Related Indirect Work • 100% Same Categories • Consistent Categories Value Ranges Meetings G, N, S Time Range Recruiting - HR G, S Low 0.2 hr Germany – HR-Related Training - Self S, U High 3.5 hr NEWAAT Training Self Training - Others S, U Training - Both G, N Next Top 2 3.0 hrs NEWAAT - Meetings 1.5 hrs Ukraine – Training Both Although all offices had training for self & others, Germany and NEWAAT combined them. Only Germany and Serbia engage in HR - Recruiting type activities. Note: Hours per Week - 20 -
- 21. Analysis Of IndirectTime Differences Technology Indirect Work • 100% Same Categories • Consistent Categories Value Ranges Non-IT Related S, U Time Range IT-Related G, N, S, U Low 0.1 hr Germany – Technology Breakdown High 1.0 hr Serbia – Non-IT Issues (Fax/Printer Difficulties) Next Top 3 0.7 hrs NEWAAT – SRS System Delays & Breakdowns 0.5 hrs Ukraine – Non-IT Fax 0.5 hrs Serbia – IT Issues All offices experience Technology Issues. Only Serbia and Ukraine listed Non-IT issues as significant. Note: Hours per Week - 21 -
- 22. Building The Calculator - 22 -
- 23. Key Baseline InformationFrom Offices 5 Attributes Collected And Culled Core Formula: DWt = 1-(IDt + OoOt ) - 23 -
- 24. Determination Of EngineProduction And Calculator Workflow - 24 -
- 25. Output Area OfThe Tool Budgeted FTE Utilized FTE Optimized FTE Required FTE ∆ in FTE • Actual "real and • Budgeted FTE • Takes the • Reflects the FTE • Number of FTE current" FTE with average utilized FTE and needed to that should be based on your standard optimizes it process the increased (+) or office's standard additional hours based on work entered volume decreased (-) workweek and (OT) worked. distribution and with zero idle over work hours per max efficiency time or Max comparator. day. (87.5%) in Capacity. current operating environment. - 25 -
- 26. Screen Shot OfCalculator Main Screen Single View Example EMEA Multi-View Capability - 26 -
- 27. Simulator Tuning Tool - 27 -
- 28. Using The Calculator - 28 -
- 29. Resource Calculator Overview Tabbed Sections The Resource Calculator Main Page Consists Of Several Sections • Monthly Volume Input Section With Default Values • Budgeted FTE Input Section With Default Values • Daily Case Volume Processed By FTE Input Sections • Output Comparison Table • Output Graphic “At-A-Glance” Indicators Each Section Contains “At-A-Glance” Indicators • Color-coded Entry Points Match Graphical Indicators On The Dashboard • Percentage Breakouts • Volume And Status Indicators • Additional Section Calculations • Percent Change Calculations Other Contents • Benchmark Comparative Values • Rules Of Thumb For Predictive “On-The-Fly” Calculations Using either the linear formula or Dead Reckoning with the graph • Output Definitions Office Selector – For Ease of Navigation - 29 -
- 30. Printing Reports Color Version B&W Version - 30 -
- 31. Support Assets HD 1080p Widescreen Live Video Overview http://vimeo.com/57635532 User’s Guide - 31 -
- 32. Thank you TimothyRoe AVP – Life Sciences Consulting 860-829-6699 - 32 -