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James Eldridge Email & Phone Number
Director, PV Operations and Compliance
at
Priovant Therapeutics
1 work email found
@priovant.com
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✓ Verified Jun 2026
4 data sources
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Current company
Role
Director, PV Operations and Compliance
Location
Round Rock, Texas, United States
Company size
Who is James Eldridge? Overview
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Quick answer
James Eldridge is listed as Director, PV Operations and Compliance at Priovant Therapeutics, a company with 70 employees, based in Round Rock, Texas, United States. AeroLeads shows a work email signal at priovant.com and a matched LinkedIn profile for James Eldridge.
James Eldridge previously worked as Director, Global Safety Surveillance at Y-Mabs Therapeutics, Inc. and Director Pharmacovigilance North America at Y-Mabs Therapeutics, Inc.. James Eldridge holds Bs Biology, Biology, General from The University Of Texas At Austin.
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Email format at Priovant Therapeutics
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{first}.{last}@priovant.com
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Profile bio
About James Eldridge
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.
Listed skills include Validation, Gmp, Regulatory Affairs, Quality System, and 23 others.
Current workplace
James Eldridge's current company
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Priovant Therapeutics
9 roles
James Eldridge work experience
A career timeline built from the work history available for this profile.
Director, Global Safety Surveillance
Current- Oversight of global clinical and post-marketing safety surveillance tasks including but not limited to: o Medical review of Individual Case Safety Reports from global sources o Signal Detection o Aggregate Reports.
- Maintain awareness of Pharmacovigilance regulatory requirements and developments
- Provide PV support for marketing applications and regulatory requests for information
- Drive development of PV manuscripts for publication
- Clinical and Post-marketing PV document review (e.g., Protocols, Safety management Plans, PV agreements)
- Ensure training of PV and non-PV stakeholders in relevant pharmacovigilance quality documents
Feb 2023 - Present
Director Pharmacovigilance North America
CurrentHead of pharmacovigilance activities in North America and National Person responsible for Pharmacovigilance (NPPV). Maintaining an end-to-end system for Post Marketing Pharmacovigilance in Y-mAbs North America i.e., but not limited to: -Managing adverse event intake and follow-up-Medical review of Y-mAbs Individual Case Safety Reports from global.
Jan 2022 - Present
Senior Manager, Head Of Global Pharmacovigilance North America
Head of pharmacovigilance activities in North America and National Person responsible for Pharmacovigilance (NPPV). Advising on North American ICSR review and evaluation. Providing scientific advice on adverse events from North American product portfolio. Headquarter representative driving operational activities related to deliberations with FDA or Health.
Feb 2019 - Dec 2021
Drug Safety Coordinator
ICSR handling, review, and and submission to FDA and Health Canada for global product portfolio. Preparation of pharmacovigilance agreements with distributors and worldwide partners. Aggregate report preparation, review, and submission. Adverse event training for non-PV staff. Reviewing regulatory updates from FDA and Health Canada for process impacts..
Jun 2017 - Feb 2019
Regulatory Affairs Specialist
Supporting Pharmacovigilance Systems, document archiving and tracking. Annual PSUR preparation, submission, and archiving. Safety reporting to FDA, Health Canada, and USDA. Searching and reviewing scientific literature for product safety information. Risk Management Plan preparation and management. Signal detection and management. Preparation and renewal.
Apr 2015 - Jun 2017
Sr. Qa/Qc Specialist
Leading USDA audits. Providing support for QA/QC departments. Assuring the development, implementation, and verifying effectiveness of quality systems affecting all aspects of operations and distribution. Supporting the establishment of training programs for all appropriate personnel. Supporting compliance/audit readiness. Supporting aspects of customer.
Mar 2014 - Apr 2015
Qa Associate
Quality Assurance: Overseeing quality and documentation during production activities in a clean room environment. Reviewing and releasing completed production batch records and certificates of analysis for drug intermediates and final drug product. Writing and revise batch records for production use. Writing and circulating process deviation reports and.
Aug 2011 - Mar 2014
Lab Technician Ii
Quality Control: Sampling and testing water, surfaces, air, pharmaceutical drugs, and intravenous bags for bacterial titer. Quality Assurance: Investigating microbial bioburden excursions and writing reports to detail findings. Entering and auditing biological data for approval and product release. Assisting in autoclave validation for intravenous bag.
Sep 2008 - Aug 2011
2 education records
James Eldridge education
Bs Biology, Biology, General
The University Of Texas At Austin
Bachelor Of Science (Bs), Biology, General
The University Of Texas At Austin
FAQ
Frequently asked questions about James Eldridge
Quick answers generated from the profile data available on this page.
What company does James Eldridge work for?
James Eldridge works for Priovant Therapeutics.
What is James Eldridge's role at Priovant Therapeutics?
James Eldridge is listed as Director, PV Operations and Compliance at Priovant Therapeutics.
What is James Eldridge's email address?
AeroLeads has found 1 work email signal at @priovant.com for James Eldridge at Priovant Therapeutics.
Where is James Eldridge based?
James Eldridge is based in Round Rock, Texas, United States while working with Priovant Therapeutics.
What companies has James Eldridge worked for?
James Eldridge has worked for Priovant Therapeutics, Y-Mabs Therapeutics, Inc., Alk, Xbiotech Usa Inc., and Hospira.
How can I contact James Eldridge?
You can use AeroLeads to view verified contact signals for James Eldridge at Priovant Therapeutics, including work email, phone, and LinkedIn data when available.
What schools did James Eldridge attend?
James Eldridge holds Bs Biology, Biology, General from The University Of Texas At Austin.
What skills is James Eldridge known for?
James Eldridge is listed with skills including Validation, Gmp, Regulatory Affairs, Quality System, Sop, Biotechnology, Quality Assurance, and Pharmacovigilance.
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