Director, Head of Pharmacovigilance System Master File WorldWide Patient Safety

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. The Worldwide Patient Safety (WWPS) 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 • Lead maintenance of BMS’ Pharmacovigilance System Master File (PSMF). • Ensure continuous oversight of BMS’ Pharmacovigilance System and awareness of Pharmacovigilance related activities and topics to ensure seamless continuity of EEA QPPV responsibilities/BMS PV system. • Involvement in QMS initiatives or projects impacting PSMF • Global Process Lead (GPL) for PSMF Position Responsibilities • Manage PSMF team to ensure ongoing maintenance of BMS’ Pharmacovigilance System Master File including the oversight and overall coordination of the local required PSMFs across different markets • Ensure collaboration with the EEA QPPV and key WWPS stakeholders to ensure continuous oversight of BMS’ Pharmacovigilance System and awareness of Pharmacovigilance related activities and topics to ensure seamless continuity of EEA QPPV responsibilities/BMS PV system. • Represent PSMF office in key forum/projects impacting PSMF • Involvement in QMS initiatives or projects impacting PSMF • Lead “PSMF and EV-Operations” team • EudraVigilance Account Maintenance Oversight /Trusted deputy for Eudravigilance Oversight • Coordinate the support -as PSMF team- efforts around Audit/Inspection readiness & Preparation for Regulatory Inspections in close cooperation with key WWPS functions • Manage GxP inspections/audits for PSMF related topics and interviews • Collaborate with PV Compliance and Quality Risk Management function -in WWPS- in relation to quality standards and metrics for PSMF • Coordinate training related to PSMF and PSMF e-system maintenance in close partnership with IT Business Partner/Digital Capability Management team Degree Requirements • University degree (preferably health or life science) Experience Requirements • At least 10 years in the Pharmaceutical Industry, usually with at least 5 years’ experience of working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, Quality or Medical Information) within the pharmaceutical industry, medical or Regulatory environment. Experience in people management and preferably with remote management experience too. Key Competency Requirements • Demonstrated strong, effective organizational, facilitation, interpersonal and communicating skills with cross-functional. • Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding PSMF. • Utilizes effective decision-making and a problem-solving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues, while retaining accountability. • Ability to manage multiple tasks and utilize effective problem-solving approaches and independently follows up and resolves outstanding issues. • Successful and creative negotiation of difficult safety/compliance issues. • Ability to manage strategic business changes and to adapt to changing business needs, conditions, and work responsibilities. • Microsoft Suite • Other systems as needed Travel Required • Travels required in this position, worldwide. 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.