|Category||Medical and Regulatory Affairs||Job type||Full-Time|
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Pharmacovigilance Associate is a member of the Epidemiology, Safety Science and Analytics group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities.
Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional Safety Management Teams (SMTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams.
Creates meeting agendas for SMT and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.
Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.
Assesses and appropriately elevates issues impacting key SMT activities, milestones, documents to the appropriate WWPS colleagues.
Leads, plans, organizes, and forecasts requirements and/or resources based on Book of Work and other upcoming tasks and activities for assigned product portfolio.
Executes searches of the corporate safety database, RAVE database, and worldwide literature, applying critical thinking and independent research skills to ensure the information is appropriate and usable.
Applies medical, life science and general scientific knowledge and expertise to create and manage plans for designated projects.
Signal Detection Support
Schedules Safety Data Review meetings and attends as able
Locate and file signal reports
Schedule and file AWARE frequency reports
Signal log entry
Maintain online content management system (SharePoint Online) and electronic files for assigned product portfolio
Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
Minimum of 2 years' professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience.
Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.
Ideal Candidates Would Also Have
Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.
Extensive experience in the analysis and communication of data and information to key stakeholders.
Project or program management experience and/or qualifications
Experience in working with committees and diverse teams
US military experience will be considered towards industry and professional experience requirements
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.