- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and operations. - Supports Head Global Strategy and Operations for Global RD/ PV /MA QA relevant activities including QQR, monthly quality report, team ... presentation, meeting agenda and meeting minutes. - Involve and attend the Global RD/ PV /MA QA strategic meeting and create the draft of presentation, meeting… more
- Amicus Therapeutics (Marlow, OK)
- …living with rare metabolic diseases. Position Summary The Snr. PV Quality Systems Associate is responsible for supporting the Assoc. Director , PV Quality ... Sr Associate , PV Quality Systems Location Marlow,...Sr Associate , PV Quality Systems Location Marlow, UK Requisition ID...PV System; Sub-file requirements ensuring alignment with the global PSMF. . Support GDS colleagues with PV… more
- ThermoFisher Scientific (Greenville, NC)
- …goals. Oversees compliance with all relevant company policies, procedures and global regulations. Guides managers and trains project team members as appropriate. ... the requirements of the role. Knowledge, Skills and Abilities: Expertise in global regulatory requirements for adverse event reporting, ICH safety guidelines, GCP… more
- Fujifilm (Columbus, OH)
- …The following Manager/supervisor level roles will directly report to the Senior Director Global Quality Systems: Director QA, Associate Director QA, ... **Overview** The Senior Director Global Quality Assurance, Audits &...Management Team for other inspection types (eg GLP/GLP and PV inspections) + Other duties as assigned **Working Conditions… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy ... position is responsible to support the implementation of the Global R&D PV QA organizational strategy. This...and Operations. In collaboration with the Associate Director Global Strategy and Operations and Head… more
- Boehringer Ingelheim (Ridgefield, CT)
- …addressing changing global regulatory environment). + In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that ... **Description** The Director has responsibility for pharmacovigilance risk management activities...risk management activities of marketed and/or investigational compounds on global level. This may include a portfolio of products/investigation… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ ... of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director , GVP QML + Engage with, ... and liaise with multiple cross-functional collaborators whose work impacts the Regeneron global PV system, including but not limited to: Global Patient… more
- Lilly (Rockford, IL)
- …visits if necessary. + Inform properly and in a timely manner to TS/MS Associate Director about project status, issues, etc. Identifying issues root case and ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more