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Associate Director, Safety Science

Company: Bristol-Myers Squibb
Location: Toms River
Posted on: February 23, 2021

Job Description:

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. Key Responsibilities will include, but are not limited to, the following: General Responsibilities Provides support to LPSP in activities relating to monitoring and management of Product's emerging safety profile Leads the logistics/coordination of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, minutes/communication and preparation of materials, in support of the LPSP Drafts materials (Slides, etc.) in preparation of Company Safety Committee (CSC)meetings Leads signal detection activities (evaluation and tracking) by conducting review and synthesis of key safety information May lead ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile Provides support to LPSPs for Product Quality issue and inquiries from external department (e.g. Legal, clinical, RA, etc.) Provides input and support safety publication strategy Post-marketing Support Contributes to development of signal detection strategy with consideration for integrating quantitative data mining methods and qualitative approaches Provides support to LPSP in development of risk mitigation strategies Leads Safety Topic Review development and authorship Leads ad-hoc regulatory safety requests preparation by obtaining and analyzing data from various sources to assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile Authors or provides content for safety sections of documents such as aggregate safety reports (PSUR/DSUR), Company Core Data Sheet, Risk Management Plans, and Events of Interest Surveillance Documents Drafts and conduct safety labeling activities for assigned products Performs literature review and QC Trial Safety Support Serves as the Lead Safety Scientist for several compounds and may oversee the operational execution of all safety-related clinical trial activities May lead the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated) May oversee and completes study-level activities (as needed): risk/benefit assessment for EU CTAs, protocol and statistical outputs (e.g. tables, listings & graphs [TLGs]) Authors or provides content for safety sections of documents such as Investigator's Brochures, Aggregate Safety Reports (PSUR/DSUR), Annual Reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans Provides support for the lead safety physician in the strategy and authoring of integrated submission documents Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds Assists the lead product safety physician with the management of the product's benefit/risk profile Departmental Activities Leads preparation for regulatory inspections with evaluation of current processes and documentation, and may serve as the SME Liaises with all TA staff and maintain an effective and collaborative product safety team Trains and mentors junior safety scientists and/or other safety staff Cross-Functional Activities Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, including SOPs and Work Practices Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include authorship of SOPs and Work Practices Leads interactions with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management Key Relationships Department staff, peers and management Lead Product Safety Physicians Clinical Operations Data Management Clinical Research Scientists Medical Writing Case Management / LDSO Global Medical Affairs Regulatory Affairs Clinical Quality Assurance Governance Participate and/or provide input to materials and strategies at meetings including but not limited to: SMT - Safety Management Teams DMC - Data Monitoring Committees - internal or external Product Development Team Clinical Study Team Qualifications/Experience Education Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience Relevant Industry Experience At least 6-8 years of relevant pharmaceutical industry experience Previous experience in Safety or Clinical Development or Operations is required Decision-Making & Change Agility Conflict Management Relationship Management Communication/Writing Results-Drive Self-Awareness & Perspective Organization Skill & Political Savvy 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. W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Keywords: Bristol-Myers Squibb, Brick , Associate Director, Safety Science, Executive , Toms River, New Jersey

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