Global Literature Surveillance Project
Our Approach
Transition and Onboarding
Initial Team and ETLQ Team: Deployment of an Empowered Training, Learning & Quality (ETLQ) team which comprised some of our existing team members and new hires whose experience exceeded the required minimum. This team remained active throughout the project implementation to be the group to provide training & guidance, to review complex cases, and to share learning during daily/weekly huddles.
Rapid Recruitment: Onboarding of experienced safety associates in the team and deployment of Drug Safety Physicians to guide/mentor the team and develop training protocols
Robust Communication: Identified and deployed SMEs for each functional area: project management, technical leadership, quality function, technology function, commercial/finance etc. to ensure rapid progress in the project deployment.
Stabilization Approach and Governance
Hands on Training: Team Training on software platform with review of over 60,000 publications in the test environment during training-mentorship program
Hands on practical pre-Go-Live simulation: Volume based Go-Live simulations for 2 scenarios – 100% volume. Executed successfully by Soterius with feedback and learning sessions for both simulations.
Mentorship Circles: 1 SME for 3-4 personnel providing close personal support and supervision.
Project Collaboration: Daily Huddles, regular interaction amongst the Soterius SMEs and Client’s SME to discuss urgent issues and meetings to discuss project progress
Governance: In-Person Governance meetings to monitor pilot results, feedback on process improvements, deployment preparation and Go-Live.
Outcome
Successful project implementation
100% compliance to the 5 key milestones (including hiring, training, pilot phase) set up by the client till Go-Live.
Performing global literature surveillance with over 150,000 literature publications annually with 100% compliance to timelines and 99% quality KPIs.
Smooth Go-Live and transition with no down-time or delays
About Soterius
Authors
Dr. Parul Singla
Sr. Director, PV Operations
Parul is an M.D. in Pharmacology with over 15 years of experience in pharmacovigilance and clinical research. He has managed the expectations of multiple clients on quality and compliance for complex analytical work in medical safety such as signal management, risk management, aggregate report preparation, and on the immediate impact case management functions. He has participated in over 10 regulatory inspections with successful outcomes. Parul has experience across pre and post marketing pharmacovigilance including signal management, aggregate report, ICSR case processing, SAE/ SUSAR processing and reporting, analysis of similar events, safety management plans, SAE reconciliation plan, etc. In his previous role, he headed the pharmacovigilance department of a global pharmaceutical company where he successfully accomplished global harmonization of the pharmacovigilance function to create a Centre of Excellence.
Disclaimer
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