Associate Director- Patient Safety Scientist

Working with UsChallenging. 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 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 SummaryLeads Safety Data Review (SDR) Teams. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Drafts the early safety strategy plan, the Early Development Safety Roadmap (EDSR). Authors safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), and health authority (HA) submission documents for new and expanded indications (Filing Activities). Ensures pharmacovigilance regulatory compliance.Mentors less experienced scientists and teams in aspects of project management, SMT requirements, core signal detection, safety data query responses, and contributions to specified PV sections of the PBRER and DSUR, as appropriate to meet individual or group of SMT/sub team needs.Position Responsibilities:General Product SupportLeads signal detection activities for a product's emerging safety profile.Provides strong medical writing support for PV sections of safety aggregate reports (eg, DSUR, PBRER) and analyzes data for the RSI section of the IB. Collaborates with MSAP to author and analyze data for ad hoc responses to health authorities.Contributes to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal assessment in a Signal Report drafting a preliminary conclusion.Develops strategies for safety data collection in clinical trials to further characterize adverse events of interest.Analyzes data and prepares documentation to support label updates for assigned products.Supports the European Union Qualified Person for Pharmacovigilance (EU QPPV) or other regional or local Qualified Person for safety issues relating to assigned products.Applies knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.Collaborate with the Pharmacovigilance Centre of Excellence (PVCoE) to develop report requirements and other customized safety data visualizations.Serve as liaison to Medical teams for AIMS (Asset/Indication Medical Strategy), publications, and investigator sponsored researchClinical Development & Post Marketing Product SupportLeads core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.Lead the creation and updates of EDSR proactively collect, assess, identify, characterize, manage, and minimize emerging safety concerns across all aggregated clinical trials of a product during its development.Leads SDR Teams in the review and evaluation of clinical data to support signal detection. Appropriately elevates issues impacting key SMT activities, milestones, and documents to the SMT Chair with limited or no oversight, as needed.Review of clinical documents for safety content (i.e. protocols, protocol amendments, clinical study reports).Contributes to presentations for external review committees (i.e. DMC).Contributes to the Filing activities for marketing authorization applications (MAA), new drug applications (NDA).Safety strategy preparation for pre-submission meetingsContribute to relevant safety documents such as the /Company Core Data Sheet (CCDS)/ label, Briefing book and Summary of clinical safety.Author HA safety query responsesContributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.Provides guidance to junior scientists' for reviewing and authoring of safety data/ad hoc queries and other documents.Contributes to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.Provides input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.Facilitate the review and evaluation of Serious Adverse Reactions for inclusion in the Investigator Brochure Reference Safety Information (IB RSI), including presentation to SMT to ensure alignment. Author the IB RSI table for multiple products with limited or no oversight.Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with limited or no oversight.Department ActivitiesParticipates in improvement projects. Assist the Patient Safety Scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.Supports preparation for regulatory inspections and audits for evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.Assists the team and senior management in all forms of issue management and crisis management.Liaises with all TA staff and maintain an effective and collaborative safety team.Supports hiring & orientation.Cross Functional ActivitiesSupports process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.Supports the development of strategic plans for safety differentiation of BMS products.Builds cross functional relationships with SMT membership and stakeholders.Leadership BehaviorsProficientSeek feedback and best practices for continued developmentDegree RequirementsScientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.Experience Requirements6 - 8 years relevant Pharmacovigilance/Pharmaceutical Industry experience; Ability to mentor others.Key Competency RequirementsPartners with Medical Safety Assessment Physician (MSAP) to plan, lead, and advance programs.Good working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.Good working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)Ability to work well in cross-functional teams.Routinely takes initiativeAbility to collaborative and communication skills with scientific subject matter.Ability to make good decisions based upon a mixture of analysis, knowledge, experience, and judgment.Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (e.g., clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).Good understanding aspects and methods for data analysis, interpretation and presentation.Possess good working skills in MS Word, Excel and PowerPoint, including statisticsIf 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 CareersWith 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.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.