Senior Manager Patient Safety

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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 Role and responsibilities Performs with little or no supervision the required pharmacovigilance/patient safety activities listed below in line with local regulatory and relevant legal requirements and BMS procedures. May take overall responsibility to manage either the PV function or the PV team (people management) for the assigned local affiliate. Acts as PV Responsible in the absence of Head of Patient Safety of the Country/Hub where required. Provides guidance to team members, where required, and assists the Head of Patient Safety in day-to-day management of the local Patient Safety function. 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 Experience Requirements 3-5 years’ experience of working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment Key Competency Requirements Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within GPVE and externally. Demonstrates a good understanding of the BMS organization, in particular the Global and International/Regional Safety groups and relevant local departments e.g. Regulatory and Clinical Teams. Knows where to go to for information and how the groups interact. 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/Patient Safety HQ and externally. Sets consistent standards for others in local PV team to follow. Excellent 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 is able to represent the local Patient Safety function on cross-functional teams, providing input on drug safety issues. With support leads cross-functional teams for Risk Management and other safety related matters. Understands the importance of pharmacovigilance within the organization and increases recognition as a PV expert. 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. Provides support to other PV Associates as required. Demonstrated ability to comply with relevant internal and external processes/guidelines/regulations. Strong ability to identify, address, resolve and communicates safety issues and performs root cause analysis Travel Required (nature and frequency). Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars. Le français est la langue de travail au Québec. Toutefois, ce poste nécessite une maîtrise de l’anglais, tant à l’oral qu’à l’écrit, en raison d’interactions régulières avec des partenaires, équipes et parties prenantes situés à l’extérieur du Québec. *** French Version *** Le groupe Sécurité des patients à l'échelle mondiale est responsable d'assurer la sécurité de nos médicaments : le groupe Sécurité des patients à l'échelle mondiale est responsable des livrables de pharmacovigilance et de pharmaco-épidémiologie, y compris la surveillance de la sécurité des cas individuels et agrégés, la déclaration de sécurité, la contribution à l'évaluation des bénéfices et des risques, la planification et la stratégie de gestion des risques, ainsi que l'exécution de certains engagements postcommercialisation, et il veille au respect des exigences réglementaires mondiales. Responsabilités du rôle Exécute, avec peu ou pas de supervision, les activités de pharmacovigilance/sécurité des patients requises énumérées ci-dessous, conformément aux exigences réglementaires locales et aux exigences légales pertinentes, ainsi qu'aux procédures de BMS. Peut assumer la responsabilité globale de gérer la fonction PV ou l'équipe PV (gestion du personnel) pour la filiale locale assignée. Agit à titre de responsable PV en l'absence du chef de la sécurité des patients du pays ou de la plaque régionale, au besoin. Offre des conseils aux membres de l'équipe, au besoin, et aide le chef de la sécurité des patients dans la gestion quotidienne de la fonction locale de sécurité des patients. Plans de gestion des risques Fourniture de renseignements sur la sécurité Mise en œuvre de l'état de préparation aux audits et aux inspections de PV Planification, traitement et déclaration des rapports agrégés aux autorités de santé (HA) et aux comités d'éthique (EC) (au besoin) Maintien de la sensibilisation et de la formation en PV Mise en œuvre des ententes de pharmacovigilance Collecte, suivi et transmission des cas d'effets indésirables spontanés, tirés de la littérature, sollicités et postcommercialisation (selon le cas) Soumission des cas individuels aux auto