Senior Specialist, International Patient Safety

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Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support Aggregate Report related activities. Maintenance of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets. Oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators. PV activity planning and tracking e.g. signal communications to Health Authorities. Collaborate and support cross-functional teams to ensure effective conduct of PV activities. PV Audit and Inspection support (including preparation, conduct and follow-up actions.) The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required. Functional and Managerial reporting lines into IPS. Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team. Strong interpersonal, verbal and written communication skills, including the ability to communicate effectively across geographies and cultures, both live interactions and virtually. Able to research, compile and provide safety information in a clear, concise manner. An understanding of local, regional and any other relevant legislation regarding PV (e.g. ICH, CIOMS). Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines. Utilizes effective problem-solving approaches to address PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations. Operational Skills: Technical Proficiency: Basic use of standard operational software and tools for automation Process Management: Understanding of current processes and ability to evaluate and suggest digital improvements. Problem-Solving: Addresses straightforward problems with simple digital solutions. Analytical Skills: Data Management: Processes and records data and information in structured computer readable formats Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system wide impact. Data Analysis: Can perform basic data gathering and reporting using standard tools. 1-2 years' experience of working in the pharmaceutical industry or a medical environment. Ideally having provided PV or medical/scientific information service in a health care environment. University degree (preferably life science) or nursing qualification. Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency) Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highe

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