**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 . RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Vice President, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles. The VP works cross-functionally with clinical, regulatory, medical affairs, quality, and commercial teams to support the safe use of products globally. **Responsibilities** Pharmacovigilance Strategy and Oversight · Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH). · Oversee end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment. · Establish and maintain robust safety governance structures, ensuring alignment with company objectives and industry best practices. Safety Science and Risk Management · Direct safety evaluation and risk management for clinical and post-marketing products, including benefit-risk assessments, aggregate reporting, and product safety strategy. · Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns. · Oversee safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries. Cross-Functional Leadership and Stakeholder Engagement · Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies. · Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety. · Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization's safety profile. Team Leadership and Development · Lead and mentor a high-performing pharmacovigilance and safety science team, fostering a culture of collaboration, accountability, and scientific excellence. · Define and implement processes for continuous improvement within PV operations, safety science, and risk management. · Manage the PV budget, ensuring alignment with organizational priorities and effective use of resources. · Up to 25% travel if not located in San Diego. **Education and Experience** · MD, PharmD, PhD, or other advanced degree in a relevant field. · 15+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry, with a proven track record of leadership. Experience in Solid Tumors Oncology is required. · In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH. · Strong understanding of clinical development, post-marketing safety, and regulatory submissions. · Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting. · Experience interacting with global regulatory authorities and scientific advisory bodies. · Exceptional leadership, strategic thinking, and communication skills. **Skills and Qualifications** · Experience leading a large team within a global organization. · Proven ability to work effectively in a matrixed, cross-functional environment. · Demonstrated commitment to patient safety and ethics in medical practice. The starting compensation for this job is a range from $312,000 - $390,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. \#RayzeBio 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:** R1587924 **Updated:** 2024-12-26 03:26:58.475 UTC **Location:** San Diego-CA 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.