Senior Specialist Patient Safety EU Distributor Markets

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. Job Title - Senior Specialist, Patient Safety Division - Research and Development / Global Regulatory, Safety and Biometrics / Worldwide Patient Safety / International PV 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 Is responsible for performing some or all of the required core pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures, under the supervision of the LMPS Lead (or designee). Position Responsibilities • Risk management plans • Provision of safety information • Implementation of PV Audit and Inspection Readiness • Planning, processing and reporting of Aggregate Reports to HA and EC (as required) • Maintenance of PV Awareness and Training • Implementation of Pharmacovigilance Agreements • As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases • Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required) • Local Market Safety Data Quality • Note: for greater detail of the specific responsibilities and duties refer to the International Pharmacovigilance Core Activities of the Local Market PV Personnel. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Degree Requirements - University degree (preferably life science) or nursing qualification. Experience Requirements: 2-3 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. Key Competency Requirements • Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within GPVE and externally. • Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups. Has a good understanding of relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company). • Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local /regional team and GPVE HQ as appropriate. • An understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for Pharmacovigilance. • Maintains an awareness of the safety profile and any emerging PV issues with BMS products (marketed or investigational )in the local affiliate and with support able to represent the local PV function on cross functional teams, providing input on drug safety issues. • Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work in order to meet strict deadlines. Utilizes effective problem-solving approaches to solve PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations. 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.