Global Case Management Associate

4 weeks ago

Ridgefield, United States McInnis Inc. Full time
Job DescriptionJob Description

*This position is onsite in Ridgefield, CT & remote*

Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.  

Duties & Responsibilities: 

  • Daily submissions of follow-up queries to appropriate adverse event reporters and QC of follow-up queries 
    • Deliverables: GCM associates are responsible for sending follow-up queries to US domestic reporters of adverse event reports. These queries are usually sent to provide further information, updates, or requests related to previously submitted adverse event reports. Additionally, GCM associates review queries initiated in the safety database to ensure that the purpose of the follow-up is communicated in a professional manner. 
    • Responsibilities – The GCM team is responsible for initiating follow-up query requests, but the submission of these requests is supported by the Global Case Management Associate in PSPV.  
  • Daily review of correspondence module in the safety database to monitor responses to follow-up queries received from adverse event reporters 
    • Deliverables: On a daily basis, GCM associates review the correspondence module in the safety database to monitor responses received from adverse event reporters regarding follow-up queries. After confirming that responses to follow-up requests have been received, the queries are closed in the global safety database. 
    • Responsibilities – Monitoring these responses to queries daily and taking appropriate actions are tasks performed independently by the Global Case Management Associate.  
  • Conducting and supporting various reconciliation-related tasks including reconciliation of Investigator Initiate Studies, License Partner’s information and Product Complaints 
    • Deliverables: Support GCM associates perform reconciliation tasks by comparing and analyzing the data from various sources, such as Investigator Initiated Studies, License Partner’s information and Product Complaints, documenting the results, discrepancies and taking appropriate actions for each data source. 
    • Responsibilities – PSPV teams and/or License Partners provide reconciliation reports to perform the reconciliation of these sources. The global Case Management Associate in PSPV supports the reconciliation process for these sources with GCM’s oversight. 
  • Support IND submission-related activities.  
    • Deliverables: Perform activities supporting the fulfillment of PSPV’s expedited reporting obligations to US FDA.  
    • Responsibilities – Ensure IND safety reports are uploaded in the correct format for Regulatory Affairs (RA). Ensure submissions performed by RA are properly documented in the safety system. This task is performed independently by the Global Case Management Associate in PSPV. 
  • Veeva review.  
    • Deliverables: Daily review of Veeva reports for potential AEs.  
    • Responsibilities – Independently review comments in Veeva for potential AE reports. Act on any potential report in a timely manner or seek clarification when needed from the source of the comment. 
  • Support ad hoc departmental projects and activities as they relate to the organizational components of ICSR processing. 
    • Deliverables: GCM associates support ad hoc departmental projects and activities related to the organizational components of ICSR processing. 

Experience and Skills Requirements: 

  • 4 Year college degree  
  • 2+ years of case report processing and auditing experience 
  • Project management and administrative skills 
  • Medical and clinical terminology 
  • Strong communication skills 
  • Proficiency in computer skills, with direct working experience in multiple electronic platforms 
  • MS Office skills 

Job Type:  Full-time  

Hybrid position  

Ridgefield, CT 

Powered by JazzHR

vhAy8ifsg2

  • Global Case Management Associate

    6 days ago

    Ridgefield, United States McInnis Inc. Full time

    *This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support. Duties & Responsibilities: Daily submissions of follow-up queries to appropriate adverse...

  • Global Case Management Associate

    1 month ago

    Ridgefield, United States McInnis Inc. Full time

    *This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:Daily submissions of follow-up queries to appropriate adverse...

  • Global Case Management Associate

    2 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This position is onsite in Ridgefield, CT & remote* Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support. Duties & Responsibilities: Daily submissions of follow-up queries to appropriate...

  • Global Case Management Associate

    4 days ago

    Ridgefield, United States McInnis Inc. Full time

    *This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:Daily submissions of follow-up queries to appropriate adverse...

  • Supply Chain Management Associate

    4 weeks ago

    Ridgefield Park, United States Samsung Electronics Full time

    Position Summary Samsung Electronic America’s Supply Chain Team is responsible for ensuring product availability to meet forecasted demand by the Sales Subsidiary. Forecasts are generated via consensus calls with Sales Teams, Marketing Teams, and with the Samsung Global Operations Center and tracked using spreadsheets, SAP, and Samsung Systems and...

  • Clinical Administrative Associate

    2 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Clinical Administrative Associate

    4 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    Job DescriptionJob Description*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational...

  • Clinical Administrative Associate

    1 month ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Clinical Administrative Associate

    3 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Associate Director/Sr. Associate Director

    4 weeks ago

    Ridgefield, United States Boehringer Ingelheim Pharmaceuticals Full time

    Description The Associate Director/Sr. Associate Director, Cardiovascular-Renal Sales is responsible for the Sales team within the assigned geography in the US. This includes the development of the district level CRM business plan and implementation of the BIPI sales/marketing plan to assure optimal market penetration of BIPI and co-promoted products within...

  • Clinical Monitoring Associate

    4 weeks ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...

  • Clinical Monitoring Associate/clinical Trail

    1 month ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...

  • Clinical Monitoring Associate/clinical Trail

    1 month ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Department: CD O Site Monitoring - USBB20 Job Category: Clinical and Scientific Job Title: Site Monitoring Lead Duties: Trial Preparation: - Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of...

  • SR AD, Public Relations and Comms

    2 weeks ago

    Ridgefield, United States Boehringer Ingelheim Full time

    Description Advances patient health by developing and implementing internal and external communications programs, including public relations and internal/employee communications, that support the short- and long-term business objectives of BIPI/BIUSA associated with prescription medicines across the entire product life-cycle, including traditional and...

  • Sourcing Manager/Contract management/RFP process

    3 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionJob Title: Sourcing ManagerDuties: - Implement complex Category Strategy following TOM and develop it for corporate center led model (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.- Bring potential innovation to Client and local market intelligence.- Identify, evaluate and...

  • Sourcing Manager/Contract management, supplier relationship

    3 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionSourcing ManagerDuties:- Local Implementation to Category Strategy following TOM (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.Identify, evaluate and classify sourcing risks and Manage risk exposure with mitigation measures.- Identify and evaluate existing and potential local...

  • SR AD, Public Relations and Comms

    2 weeks ago

    Ridgefield, United States Boehringer Ingelheim Full time

    **Description** Advances patient health by developing and implementing internal and external communications programs, including public relations and internal/employee communications, that support the short- and long-term business objectives of BIPI/BIUSA associated with prescription medicines across the entire product life-cycle, including traditional and...

  • Project Manager IT

    4 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionTITLE: Project Manager - I JOB SUMMARYUnder general supervision, responsible for all aspects of various projects of a less complex nature.Interfaces with all areas affected or supporting the project.Responsible for assembling project time, assigning individual responsibilities, identifying appropriate resources needed, and...

  • Supply Chain Manager/ Supply Chain Analyst

    1 month ago

    Ridgefield, United States Adientone Full time

    In your new role as Project Office Specialist, you closely collaborate with the Head of the Project Office to set-up and continuously develop the new Global CTSU Project Office. With your experience in supply chain management, you contribute to maintain and improve the global CTSU project plan templates in Planisware and act as CTSU Key-user role to ensure...

  • Pharmacovigilance and Safety

    6 days ago

    Ridgefield, United States McInnis Inc. Full time

    Pharmacovigilance and SafetyProvide services relating to adverse event reporting with a focus on the Final Review step of case processing and any other responsibilities typically associated with, but not limited to, the outlines and responsibilities detailed below.A scalable position requiring 20 - 40 hours per week.This position is...