- Pfizer (New York, NY)
- **ROLE SUMMARY** The Pharmacovigilence AI Quality Oversight Lead is responsible to oversee the strategic development and implementation for the quality ... pharmacovigilance . This involves contributing to and participating in various quality oversight activities/committees established to drive discussion and… more
- Bayer (Whippany, NJ)
- …in quality management systems relating to medical devices and pharmacovigilance . This posting will be available for application until at least November ... ** Director Medical Device Safety** At Bayer we're visionaries,...of Medical Device Safety (MDS) leads and develops global Pharmacovigilance (PV) business processes and analyses clinical data sets… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**Job Description** You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, supporting the ... cross-functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with Gilead's Quality Management System… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and ... as well as with business partners to achieve high quality and accurate labeling in support of business objectives....cross-functional labeling review team members. Responsible for the broad oversight of Core Data Sheets and US/EU label changes… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Systems Management is responsible for the strategic oversight and day-to-day management of systems that support the delivery of regulated ... organization. Metrics and Reporting: + Lead the preparation and oversight of P&P Veeva quality metrics. +...Operations (IOPs), BioAnalytical Systems (BAS), and Drug Safety and Pharmacovigilance (DSP) to ensure the EDMS meets the needs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring global DBMA quality standards for Change requests - IT Vendor Oversight and Management. Managing CSPV IT Budget for Local DSI CSPV Systems Monitoring ... searches and report output.For all data requests, perform self-QC of data to ensure quality of results. - Service Provider Oversight and Management: Oversight… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Medical Science MSES, will be primarily responsible for creating plans for ... and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early-Stage, the Director , MSES will… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. ... will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to...quality perspective in conjunction with business and Associate Director / Director , GVP QML + Engage… more