- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Information Social Media and other suppliers. Develop governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability ... agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are PV relevant and AE reporting language… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ... and report output.For all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight of Data Request… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …documents and evidence + Support with implementing and ensuring global DBMA quality standards for Change requests **IT Vendor Oversight and Management** ... and report output. + For all data requests, perform self-QC of data to ensure quality of results. **Service Provider Oversight & Management** + Oversight of… 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
- 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
- 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
