**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 rich in diversity. 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 . **Functional Area Description** The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. **Position Summary / Objective** This is a leadership role reporting to the Head of PVOpS Operational Excellence. This role is responsible for leading a team of BMS staff to support and enable the ICSR management sub-functions within PVOpS by driving business process optimization, automation in the end-to-end case processing space, providing standards, quality, & training support, and maximizing & strengthening the process and outcomes within deviation management. The role is responsible for strategic input to case processing conventions and efficiency gains. **Degree Requirements** + Responsible for building and maintaining an effective and efficient business process for end-to-end case processing. + Responsible for ensuring process optimization, improvement, and long-term sustainability that is optimally integrated with systems and follows standard methodology. + Partner with Business Operations Systems lead to ensure process is optimally leveraging system functionality. + Build role definition and clarity on key accountabilities for process steps through an enterprise lens. + Create defined optimization metrics to ensure Quality outcomes and monitor performance for associated process (es). + Develop global processes with close cooperation and input from relevant stakeholders. + Engage with Compliance, Quality & Learning team, R&D Quality Leadership, and other functional leaders to optimize procedural documents, training content and documentation, and deviation management for PVOpS. + Ensure proper and comprehensive documentation of WWPS systems ICSR/Medical Review process and database related documents. + Collaborate with other functional leaders and SMEs to define best practices and drive optimal execution of process across BMS and external partners. + Ensure process alignment with evolving regulations. + Lead across the matrix or manage high-priority, cross-functional teams. + Serve as Operational Chair of multidisciplinary governance forum PV Process Solutions to navigate cross-functional team through ambiguity towards clear and actionable decisions. + Provide data and input to continuous improvement efforts across the Safety Organization, as applicable. + Provide leadership to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, metrics, and training material changes; and use of appropriate change management and communication principles. + Maintain awareness of Culture of Excellence across BMS and adherence to BMS core behaviors. + Support development, approval, and execution for improvement projects, changes, validations, and process risk evaluations. + Ensure continuity of process through major initiatives (e.g. integration, divestiture, or reorganization). + Maintain global processes, procedures, and training materials in compliance with Global GVP requirements and BMS Quality Management System (QMS) principles of integrated, patient-centric, and risk-based decision-making. + Cultivate business relationships to provide leadership in a highly matrixed environment. + Lead benchmarking initiatives with industry peers externally to stay abreast of new ways of working and evolving technologies. **Education / Experience requirements:** Life Science Degree (MS or higher preferred) 10+ years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical or biotechnology industry, with substantial time in PV operations and case management standards. Experience in leading teams and projects. Strong background in PV process improvement and training. **Key Competency Requirements** + Deep understanding of the pharmacovigilance and pharmaceutical development and understanding of market trends and landscape + Demonstrated ability to lead with a positive culture and engage across multiple stakeholder interfaces. + Track record of successfully leading transformation change management projects including organizational evolution and process optimization + Demonstrated ability to analyze and interpret complex information through effective decision-making and planning, deliver superior business solutions. + Demonstrated ability to effectively communicate to a diverse audience, at multiple levels including senior leadership within the company, through various formats, i.e. presentations, written proposals, reports, correspondence, leading meetings and direct dialogue. + Experience in working with a range of technically and culturally diverse people, influencing them to accomplish common goal. + Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines. + Drives Innovation through identification of opportunities to leverage technology in collaboration with applicable WWPS sub-functions. + Manages relationships with key internal and external stakeholders. + Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance. + Appreciation of sense of urgency and appropriate prioritization some tasks will require. + Effectively influences others, without direct authority, in order to achieve success with individual and department priorities and projects. 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 an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1587163 **Updated:** 2024-11-16 03:34:35.434 UTC **Location:** Madison-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.