WWPS GSO PV System Excellence & QPPV support Senior Manager

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. GENERAL DESCRIPTION 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. The WWPS GSO PV System Excellence & QPPV support Senior Manager role will support the organization by: PV Intelligence: coordination for the maintenance of the local markets summary legislation sheets including checking the appropriateness of the forms and all related activities to ensure legislative changes are reviewed and addressed properly and improvement related activities QPPV Support by distributing signals, PRAC recommendations, advanced notification, PBRER assessment reports for established brand to relevant stakeholders Provide expert knowledge and information related to the coordination and submission requirements for Safety Aggregate Reports (SARs) in the EU (as applicable) QPPV analytics data generation support Strategic projects support involving WWPS organization for continuous improvements Support the development and maintenance of Resources Calculation Tools DUTIES Expertise in liaison with and coordination of: MRP and NAP PSUR/PBRERs coordination and liaison with vendor as applicable Planning responsibilities for EU Reference Date List update PRAC recommendations for established brand products Coordination of responses to the EMA (PSUR Repository) regarding assessment reports for established brand PSURs/PBRERs and liaison with vendor as applicable Partner with WWPS and external WWPS stakeholders to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the Worldwide Patient Safety organization e.g., on SAR submission Liaise with WWPS Leadership Team on core activities and ensure resources algorithm updates are completed in a timely manner Industry insight/PV intelligence related activities support Collaborate to QPPV operational support to facilitate QPPV oversight by generation of Analytics data: i.e. PSMF Metrics & KPIs, Safety Variations, QPPV Notifications Lead PV projects for continuous improvements initiatives as applicable. QUALIFICATIONS Minimum 5 years’ experience in pharmaceutical industry with at least 3 years PV exposure Scientific Degree SOFT SKILLS REQUIREMENTS Critical thinking Decision making Teamwork Organizational and follow-up skills Time management and prioritizing skills Change Management Ability to manage multiple tasks and utilize effective problem-solving approaches and follows up and resolves outstanding issues Working in an international environment Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs). Microsoft Suite, including MS Project Other systems as needed 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.