James Eldridge Email & Phone Number

Austin, Tx, Us

New York, Ny, Us

• 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 including but not limited to PSUR, DSUR, and PADER o Literature Searches o Risk Management Plans o Company Core Safety Information development and maintenance o Support DMC and ongoing clinical trial safety oversight o Chair and organize Safety Committee meetings o Participate in case review meetings o PV quality documents – i.e., establish and maintain SOPs supporting surveillance activities o Provide input into to the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals)• 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• FDA inspection readiness• Support PV compliance and PV case handling• Liaise with Medical Affairs

New York, Ny, Us

Head 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 sources-PV quality documents – i.e., establish and maintain SOPs and Pharmacovigilance Agreements-PV Training -Vendor oversight/management-FDA inspection readiness-PV compliance and PV case handling-Liaise with Y-mAbs Medical Affairs-Maintaining awareness of Pharmacovigilance regulatory requirements and developments.-Providing input into to the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals)-Tracking metrics for monitoring of regulatory PV compliance-Ensuring training of PV and non-PV stakeholders in relevant pharmacovigilance quality documents

Hoersholm, Dk-2970, Dk

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 Canada including relevant face-2-face interactions and inspections. Overseeing CRO performing daily case handling activities. Supporting preparation and review of Risk Management Plans, Periodic Reports, Literature Searches, and Signal Detection. Overseeing any Post-Marketing Commitment studies. Driving updates of local labeling and company core safety information. Supporting creation and maintenance of relevant safety data exchange agreements with distributors, partners, and vendors. Preparing and maintaining standard operating procedures in relation to pharmacovigilance to ensure compliance current and upcoming legislation. Ensuring pharmacovigilance training of relevant staff.

Hoersholm, Dk-2970, Dk

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. Oversite of PV CRO handling ICSR intake and follow up. Managing all veterinary ICSRs and submission to USDA. Acting as lead for PV inspections and audits as well as PV readiness for inspections and audits. Providing Pharmacovigilance System Master File input for North America business unit. Managing CAPAs related to North American PV department. Acting as PV lead for interdepartmental projects.-Follow up and closing of CAPA’s

Hoersholm, Dk-2970, Dk

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 of Pharmacovigilance agreements with distributors and business partners. Leading local basic PV training for non-PV staff. Supporting Sunshine Act data collection and validation. Review of advertising and promotional materials. Biological product and medical device registration strategic planning. Supporting international product registration. Supporting other RA functions as needed. Supporting Quality Systems including audits, validations, change controls, complaint handling, PV and RA SOP maintenance and archiving. Leading local training and support for the Sharepoint based document control system.

Hoersholm, Dk-2970, Dk

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 and consumer complaint investigation and resolution. Inspection of received product and release for inventory. Reviewing and monitoring GMP documentation. Reviewing and updating the returns database. Non-conforming product rejection and approval. Writing and evaluating process deviation reports, change controls, and CAPAs.

Austin, Texas, Us

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 corrective action follow-ups. Continuously working to improve manufacturing and quality procedures and practices. Assisting with validation of final drug product filling. Reviewing documentation of incoming inventory items used in production activities. Manufacturing: CHO (Chinese hamster ovary) cell culturing, harvest, purification, viral filtration, formulation, aseptic filling, final inspection, and shipping of drug product. Buffer and media preparation. Working and master cell banking. Quality Control: Performing microbial, and air particle testing in the clean room environment. Performing HPLC testing on drug product, drug intermediates, and stability samples by CEX and SEC analytical methods using ChemStation and an Agilent 1100 series HPLC.

Lake Forest, Il, Us

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 sterilization. Conducting and assisting in various projects to increase the efficiency of lab testing and coordination. Working under a LEAN program to improve process efficiency.

Bs Biology, Biology, General

Bachelor Of Science (Bs), Biology, General