Viewing 1 - 8 of 11 jobs
* Ensures that all safety processes are properly supported (pharmacovigilance, signal detection, risk management, ... * Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general...
professionals in the analysis and reporting of safety data. Pharmacovigilance Develop, maintain & operate processes and systems for Signal Detection and Analysis Contribute to generation of monthly signal detection reports Contribute to...
formed epidemiology function within Clinical Safety and Pharmacovigilance , develops the vision, strategy, staffing model, and processes that will maximize the efficiency and success of DS's development programs and improve on the...
and reporting of safety data. Core Responsibilities: Pharmacovigilance - Participate in product meetings - ... /Skills - Excellent understanding of Drug Safety & Pharmacovigilance - Excellent communication skills...
experience with controlled substances preferred.MANAGER, PHARMACOVIGILANCE, NEW JERSEYPharmacovigilance Manager ... Executes exchange of information with global counterparts (Pharmacovigilance Drug Safety Europe/ROW)...
consulting with Early and Late Strategy development teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global conformance with regulatory requirements, GCP, internal standards, the pro-active...
Phase I Units, and other service providers including Pharmacovigilance audits of Affiliates and Business ... consults with Early and Late Strategy, development teams, Pharmacovigilance, Operational and Technical Services and...
direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, e.g. language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality...
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