- ThermoFisher Scientific (Waltham, MA)
- **Job Description** **Summarized Purpose:** Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region. Assess ... of the team/function with focus on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs, Medical Affairs, US Commercial… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …oversight for deviations/incidents & investigations, 3rd party/vendor oversight and liaison to support audit and inspections as applicable. Support MA/PV ... closure, and proper effectiveness checks. Support lessons learned information flow based on read outs from audits, inspections, Quality Events, regulatory… more
- Sumitomo Pharma (Trenton, NJ)
- …CTSA Associate Manager is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will be responsible for ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Johns Hopkins University (Baltimore, MD)
- …and multiple site-specific pharmaceutical sponsored trials The Sr. Research Program Manager will work in collaboration with division leadership and collaborating ... disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between the BIOS leadership and the research communities. This position… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk- based quality management ... global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at...support inspection readiness activities + Act as a primary liaison to GPS to advise on any quality issues… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership ... teams, relevant functions and other GDQ functions to lead risk- based quality management activities on all Regeneron-sponsored clinical trials,...Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on… more