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. Position Summary / Objective Is responsible for performing some or all of the required pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures,
under the direct or indirect supervision of the Head of Patient Safety of the Country/Patient Safety Hub/Cluster. 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 Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases (as applicable) 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 Patient Safety Core Activities of the Local Market Patient Safety 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 Worldwide Patient Safety 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 Worldwide Patient Safety 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 pharmacovigilance/patient safety issues with BMS products (marketed or investigational )in the local affiliate and with support able to represent the local Patient Safety 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. Travel Required Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars. 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.