Associate Director, Patient Safety Scientist (Telangana)

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 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 Signal Detection Management Safety SurveillanceDrives core signal detection and assessment activities in partnership with the SMT Chair throughout product life cycle including review of safety-related literature and quantitative signal detection Demonstrates strong capability in using a wide range of tools data sources to assess safety concerns enabling informed decision-making and proactive risk management Leads SDRMs by reviewing and evaluating clinical data to support signal detection Appropriately escalates issues impacting key SMT activities milestones and documents to the SMT Chair demonstrating sound judgment and strategic awareness Drives the strategy and execution for signal evaluation e g case-series literature review health authority claims databases promotes cross-functional collaboration authors comprehensive signal reports with clear preliminary conclusions and ensures timely tracking stakeholder engagement and documentation within the signal management system Executes strategy and provides strong medical writing for safety and risk management sections of aggregate safety documents e g DSUR PBRER PADER Executes strategy analyzes data and writes ad hoc responses to health authorities including supporting local markets in responding to risk management-related queries from local HAs and mentors less experienced scientists in this area Clinical Development Product SupportLeads the preparation review and strategic input for safety sections in key clinical trial documents such as protocols clinical study reports CSR investigator brochures IB including reference safety information RSI informed consent forms ICF and contraception language Represents Patient Safety and supports safety strategy preparation at internal and external meetings pre-submission Advisory Committees Scientific Advice data monitoring committee publications etc Submission Planning Postmarketing Product SupportExecutes on the safety strategy for regulatory filings including contributing to safety strategy key safety messages and risk management approaches Reviews and authors safety sections of marketing authorization applications MAA including safety table shells Integrated Summary of Safety ISS Summary of Clinical Safety SCS clinical overview briefing book and initial product labeling USPI CCDS SmPC Authors responses to ad hoc regulatory safety requests e g 120-day safety updates proactively sourcing and interpreting safety data to evaluate the impact of emerging safety issues on the product s benefit-risk profile Provides input into strategy analyzes data and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile Supports the EU QPPV or other regional local QP for safety issues on assigned products Risk Management Planning ExecutionResponsible for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development support Structured Benefit Risk and define the strategy for Company Core Risk Management and gaining alignment with SMT governance including collaboration with Epidemiology on risk minimization effectiveness non-interventional research NIR activities for post-authorization safety studies PASS Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans RMPs including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities Leads and oversees the creation and revisions to core additional Risk Minimization Measures aRMMs and additional Pharmacovigilance Activities aPVAs globally and locally Provides guidance to local markets and vendors for complex eg Pregnancy Prevention Programs Controlled Distribution Programs and non-complex aRMMs e g educational materials Department ActivitiesLeverages automation and innovation tools into day-to-day work with an understanding of current processes and ability to evaluate and suggest digital improvements Uses multiple data sources and AI generated outputs to support .