Safety Systems Consulting

What Pharmaceutical Firms Look For

Consultants to act as intermediaries between them and their Safety Hosting Vendors
Consultants to support their Safety System upgrades
Consultants with Safety System Configuration knowledge
Consultants to perform E2B Customizations
Consultants to maintain Change Management process
Consultants to assist with MedDRA and WHODrug upgrades
Consultants to assist with RFP process for selecting the most efficient Vendor or Tool selection
Consultants to help improve the Client's existing Safety operations procedure
Consultants to help keeping systems in sync with most up to date Health Authority guidelines
Consultants to prepare Training materials for newly implemented systems

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

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

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

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

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

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

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

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

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.

Merakee BI consultants can enhance existing Safety Operations for greater efficiency through workflow enhancements, automated case quality control, and workflow monitoring

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

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.