Bristol-Myers Squibb
Director, Medical Safety Assessment Physician
Bristol-Myers Squibb, Princeton, New Jersey, us, 08543
Director, Medical Safety Assessment Physician
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.Director, Medical Safety Assessment Physician (Immunology)Functional Area DescriptionThe Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.Position SummaryLead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.Promote collegiality and teamwork among peers. Mentor/support colleagues as a positive change agent.Minimum RequirementsDegree RequirementsMD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.Experience Requirements3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.Key Competency RequirementsUnderstanding of the drug development process. Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product. Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research. Understanding of regulatory requirements for safety assessment and action. Strong scientific analytical reasoning skills. Ability to work on multiple projects in parallel. Excellent attention to detail. Behavioral competencies necessary to work and lead within a complex matrix environment. Excellent verbal and written communication skills.If 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.
#J-18808-Ljbffr
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.Director, Medical Safety Assessment Physician (Immunology)Functional Area DescriptionThe Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.Position SummaryLead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.Promote collegiality and teamwork among peers. Mentor/support colleagues as a positive change agent.Minimum RequirementsDegree RequirementsMD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.Experience Requirements3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.Key Competency RequirementsUnderstanding of the drug development process. Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product. Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research. Understanding of regulatory requirements for safety assessment and action. Strong scientific analytical reasoning skills. Ability to work on multiple projects in parallel. Excellent attention to detail. Behavioral competencies necessary to work and lead within a complex matrix environment. Excellent verbal and written communication skills.If 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.
#J-18808-Ljbffr