James Eldridge

FAQ About James Eldridge

• What is James Eldridge's address?

  James Eldridge is located at
  Round Rock, Texas, United States

• What is James Eldridge's job title?

  James Eldridge is a
  I am a Drug Safety professional focused on organization, driving results, and accelerating organizational growth through positive leadership, interdepartmental relationship building, process improvement, and change management. I have spent over fifteen years working in the biopharmaceutical industry with a diverse background in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and Pharmacovigilance in both human and veterinary products. In-depth knowledge of the following: -Pharmacovigilance: ICSRs, PSURs, Signal Detection and Management, Benefit-Risk Evaluation, RMPs, FDA and Health Canada Reporting, SDEA/PVAs, Electronic Submissions, Literature Searches, CRO management -Regulatory Affairs: Regulatory compliance review. Providing comprehensive regulatory advice with transparency, openness, and consistency. -Quality Management Systems: Building, maintaining, and improving -National Competent Authority Coordination: Lead coordinating FDA, Health Canada, and USDA communications and inspections -Risk Management- Leading risk evaluations based on open discussion and identification of optimal risk mitigation that minimizes internal burdens and maximizes ethical outcomes. -Internal and External Auditing: ASQ CQA - Personnel and project management; Building up strong PV resources and developing effective working relationships with both internal and external partners and direct reports. -Training: Developing, coordinating, and implementing training strategies for cGMP functions. Providing effective training to local and global partners. - Overseeing global and local partner coordination to meet common deadlines and project goals. I have a strong passion for my work and my family. My goals are to leverage my experience to help ensure and improve patient safety while sharing knowledge and helping to build a strong interconnected regulatory and biopharmaceutical community. Y Mabs Therapeutics

• What industry does James Eldridge currently work in?

  James Eldridge currently works in the
  Y Mabs Therapeutics

• What is James Eldridge's area of expertise?

  James Eldridge specializes in
  I am a Drug Safety professional focused on organization, driving results, and accelerating organizational growth through positive leadership, interdepartmental relationship building, process improvement, and change management. I have spent over fifteen years working in the biopharmaceutical industry with a diverse background in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and Pharmacovigilance in both human and veterinary products. In-depth knowledge of the following: -Pharmacovigilance: ICSRs, PSURs, Signal Detection and Management, Benefit-Risk Evaluation, RMPs, FDA and Health Canada Reporting, SDEA/PVAs, Electronic Submissions, Literature Searches, CRO management -Regulatory Affairs: Regulatory compliance review. Providing comprehensive regulatory advice with transparency, openness, and consistency. -Quality Management Systems: Building, maintaining, and improving -National Competent Authority Coordination: Lead coordinating FDA, Health Canada, and USDA communications and inspections -Risk Management- Leading risk evaluations based on open discussion and identification of optimal risk mitigation that minimizes internal burdens and maximizes ethical outcomes. -Internal and External Auditing: ASQ CQA - Personnel and project management; Building up strong PV resources and developing effective working relationships with both internal and external partners and direct reports. -Training: Developing, coordinating, and implementing training strategies for cGMP functions. Providing effective training to local and global partners. - Overseeing global and local partner coordination to meet common deadlines and project goals. I have a strong passion for my work and my family. My goals are to leverage my experience to help ensure and improve patient safety while sharing knowledge and helping to build a strong interconnected regulatory and biopharmaceutical community.

• Which languages does James Eldridge speak? 

  James Eldridge speaks the following languages:
  No languages available.

• Which industries has James Eldridge previously worked in?   

  James Eldridge has prior experience in the following industries:
  Alk , Alk , Alk Abello , Alk Abello , Xbiotech Usa , Hospira

• What is James Eldridge’s work experience?  

  James Eldridge has the following professional experience:
  Y Mabs Therapeutics , Y Mabs Therapeutics , Alk , Alk , Alk Abello , Alk Abello , Xbiotech Usa , Hospira .

• How can I find James Eldridge on LinkedIn?  

  You can view James Eldridge’s
  LinkedIn profile at LinkedIn URL.

• What are James Eldridge’s work email addresses?  

  James Eldridge’s work email addresses are
  [email protected] .

• What company does James Eldridge work for?  

  James Eldridge works at
  Y Mabs Therapeutics