Position Summary / Objective Supports the Worldwide Patient Safety Vision through understanding the impact and implication of daily work on all customers of AE Processing. This commitment drives dedication to quality and accurate case handling, for overall contribution to a high performance team. Position Responsibilities Ensures the quality and accuracy of adverse event reports. Learns and navigates the intricacies of the BMS Drug Safety Databases to process adverse event reports. Relies upon medical knowledge to conduct comparisons of adverse event source documents against Safety Database screens for transcription and medical accuracy. Employs effective oral and written communication skills to ensure appropriate AE case processing and consistent documentation of medical judgment within the drug safety database. Maintains a customer service focus with internal and external GPV&E colleagues. Utilizes cultural awareness to incorporate the varying medical philosophies of regulatory bodies worldwide and the idiosyncrasies of health care delivery for effective global AE reporting. Takes personal initiative by proactively identifying innovative ways to accomplish tasks and driving toward process efficiencies. Utilizes effective organizational skills to prioritize deliverables in order to accomplish work in established timeframes. Demonstrates the ability to handle ambiguity of inquiries by identifying reporting regulations in order to provide solutions for resolution. Demonstrates strong teamwork skills to ensure that processes, procedures, and best practices are consistent across GPV&E and that regulatory requirements are met in a timely manner and with high quality. Collaborates with Medical Review Safety Physicians and Safety/ESR Scientists across therapeutic areas on case-related issues, while seeking guidance from AE Processing managers. Contributes to continuous quality improvement process through projects and other related departmental initiatives. Serves as a trainer, mentor, and guide for colleagues within GPV&E through providing perspective on the broad organizational impact on their daily work. Accountable for multiple tasks including CAPA, ICSR reconciliation, database interfaces, single case compliance, external and internal stakeholder correspondence, and prioritizes tasks according to designated criteria. Utilizes knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations in order to maintain oversight of vendor activities to ensure successful execution of tasks. Develop and execute training for alignment in processing. Collaborate with clinical trial teams and CROs to ensure SAE operational processes in outsourced clinical trials align with BMS processes. Ensure alignment and drive approval from all Stakeholders of study specific SAE Management Plans. Review and evaluate integrity of CRO SAE processes for inspection readiness.
Allen Spolden...Loss Prevention Security Officer Previous Security experience preferred Must be comfortable with face to face interactions Must be comfortable with different forms of technology Previous CCTV experience a plus Must be punctual $20.00/hr, Full-Time, Weekly...
...Regular Job Code 9704ID Employee Class Acad Prof and Admin Add to Favorite Jobs Email this Job About the Job The Curriculum Developer (Ed Prof 4-Instrctnl Des, 9704ID) is a 1.0 FTE employee at the Multidisciplinary Institute for Child Welfare (MICW). The...
...Global Elite Texas is hiring a Bilingual Client Services Representative for a work-from-home position. We seek goal-oriented individuals with leadership potential... ...company. The ideal candidate will be bilingual in Spanish and English, possess excellent communication skills...
...Position Summary: As our Lifestyle/Resident Relations Coordinator you have the opportunity to use learned and gained knowledge to assist the General Manager with daily resident functions, customer service, resident retention, event planning, networking, and marketing...
...Analyst-Compliance - AML Investigations Phoenix, AZ, United States Sandy, UT, United States Sunrise, FL, United States (Hybrid) Job Description American Express's Global Financial Crimes Surveillance Unit (GFCSU) and the US Investigations Unit (USIU) are...