- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and process improvements. + Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidence + ... Argus Safety backend database. + Strong knowledge of Oracle Argus Safety System , PV Case Intake, PV Reports, Signal Detection and Analytics Reporting… more
- United Therapeutics (Trenton, NJ)
- …for cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key ... role in management and oversight of end-to-end case safety management activities spanning across our global commercial product...with vendors and other team members of GPS & PV to ensure process compliance + Training and Development:… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, ... the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be...create Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation within their program +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization...for CS Physician and Data Management for study related safety reporting. Will also act as PV … more
- AbbVie (Branchburg, NJ)
- …for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents *Analyze and interpret ... Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose Responsible for supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Signal Management Process Excellence in Cambridge, MA, where ... Signal Management and Innovation (SMI) team, you will report to the Senior Director , Head, Signal Management and Innovation (SMI). You will review and support… more