- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by ... procedures through partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA… more
- ThermoFisher Scientific (Waltham, MA)
- **Job Description** **Summarized Purpose:** Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region. Assess ... needed enhance and/or develop new processes while assuring consistency with global standards. **Essential Functions:** + Increase the visibility of the team/function… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines ... on real-world evidence, and creating hope for all facing illness. As a Manager , Drug Safety Data, you will be responsible for managing and analyzing safety… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and ... quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr.... Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at… 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 ... and audits. + Global safety planning and coordination member to support global initiatives. + Collaborates with Quality on corrective action and preventative… more
- Takeda Pharmaceuticals (Boston, MA)
- …submission of high- quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. As part of the Patient Safety & ... therapies to patients worldwide. Join Takeda as a Senior Manager , Aggregate Safety Reporting in Cambridge, MA, where you...report and other functional deliverables are completed with high quality . + Responsible for global leadership and… more
- Takeda Pharmaceuticals (Boston, MA)
- …document repositories per Medical Affairs SOPs and processes. + Coordinate with Pharmacovigilance , Quality and Regulatory Affairs to respond to external audits ... as the therapeutic area operational lead for interfacing with internal stakeholders ( Global , Regional and Local Medical Leads, TA Medical Heads) and external… more
- Amgen (Thousand Oaks, CA)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Quality Compliance Manager , Safety & Medical Quality ** **Live** ... Development teams in GxP audits from business partners. + Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or research… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality ... or defect and assess across products and/or device associations. + Partner with Global Product Safety and Pharmacovigilance to assess complaint and AEs for… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Product Complaint Manager is responsible for being the Subject Matter Expert on the product complaint and adverse events/product complaint ... but are not limited to interaction with medical and non-medical contact centers, quality and investigation sites to facilitate correct, quality and timely… more