Safety Systems Consulting
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What Pharmaceutical Firms Look For
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Consultants to act as intermediaries between them and their Safety Hosting Vendors
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Consultants to support their Safety System upgrades
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Consultants with Safety System Configuration knowledge
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Consultants to perform E2B Customizations
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Consultants to maintain Change Management process
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Consultants to assist with MedDRA and WHODrug upgrades
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Consultants to assist with RFP process for selecting the most efficient Vendor or Tool selection
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Consultants to help improve the Client's existing Safety operations procedure
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Consultants to help keeping systems in sync with most up to date Health Authority guidelines
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Consultants to prepare Training materials for newly implemented systems
02
How We Can Help
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Merakee BI techno-functional consultants possess a profound grasp of PV Operations, Risk Management terminology, and a technical perspective on Safety systems. They are highly skilled in acting as representatives for Pharmaceutical Companies, enabling seamless communication between these companies and their Safety Hosting Vendors to enhance process efficiency
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Merakee BI techno-functional consultants have extensive experience in overseeing multiple Safety System upgrades. They have a track record of conducting thorough impact assessments on existing custom reports, processes, interfaces, and other dependencies. These consultants are also proficient in drafting and reviewing system upgrade requirements, validation documents, and executing User Acceptance Testing scripts on behalf of clients
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Merakee BI consultants possess a profound understanding of Safety Systems configuration as well as Study Protocol documents, enabling them to effectively execute Study, Product, and License configurations
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Merakee BI consultants have an in-depth comprehension of Reporting Rules configuration and PV agreements with License Partners, allowing them to proficiently draft and configure Reporting Rules for the timely submission of cases
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Merakee BI consultants have comprehensive knowledge of other system configurations including but not limited to Case Priority, Field Validations, Common Profile Switches, Workflow Setup, User-Defined fields etc
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Merakee BI consultants possess the capability to customize out of box E2B profiles for fixing any issues related to case exchanges with License Partners and Regulatory Agencies
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Merakee BI consultants can handle and oversee the System changes as safety system owners and ensuring the changes have been made as per the client's SOPs and standards
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Merakee BI consultants bring significant expertise in creating comprehensive impact assessment documents for MedDRA Upgrades, which the Medical Risk Management team can review. They also excel in conducting retrospective impact assessments for products in existing that were not previously coded with the dictionary
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Merakee BI consultants can support clients in drafting RFPs, as well as in preparing and evaluating responses for the implementation of new Patient Safety Systems, Signal Management Tool adoption, or Vendor selection.
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Merakee BI consultants can enhance existing Safety Operations for greater efficiency through workflow enhancements, automated case quality control, and workflow monitoring
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Merakee BI consultants invest ample time in staying current with the latest guidelines from Regulatory Authorities. They assist clients in conducting impact assessments on their existing systems and procedural documents, recommending and implementing necessary updates to ensure compliance
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Merakee BI consultants are capable of developing training materials and delivering training sessions for the newly implemented Patient Safety systems, Signal Management tools, and third-party Reporting Tools, tailored to the client's specific usage requirements.