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.
Benefits Medical & Dental, 401K and PTO.
Burns & McDonnell is seeking a Mechanical Engineer in Los Angeles to work on a variety of innovative projects, including power and healthcare facilities. The role involves performing mechanical design from conception through to completion and adapting plans based on client...
...flexible and personalized learning experiences online for students in kindergarten through 12th grade and beyond. German & French Teacher Laurel Springs School | Remote, United States | Full-Time What We Offer ~ Competitive compensation package ~ Medical...
A local food company is hiring a Vendor Booth Consultant to promote and sell handcrafted products at various events. The role offers flexible scheduling and is commission-based, ideal for self-starters with sales experience. Responsibilities include setting up booths,...
...individual to join our growing team as Dev Ops Cloud Developer . In this role, you will be... ...bachelors degree in computer science, engineering, or related field; or equivalent work... ...Solutions ArchitectProfessional, Google Cloud Professional Cloud Architect, Microsoft...
...and is open 24 hours, seven days a week. Contractors in this role play an integral part in the operation as front-line workers. The Newspaper Carrier will support the distribution of newspapers to home delivery subscribers. This role is a part-time independent contractor...