- Actalent (New York, NY)
- Description The PV Associate Director is accountable for the development and execution of global pharmacovigilance processes and deliverables. This position ... PV to ensure development and continuous harmonized operations of global pharmacovigilance activities and maintain highest standards for integrated functioning. * As… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and interpersonal… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ... implementation + Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. **Functional Expertise:** ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance , CROs, and partners to ensure high quality coding...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more