Medical Director, Medical Safety Officer

Responsibilities

• Support Business Unit Medical Safety Specialist (MSS) and Regional Safety Specialists (RSS) for their respective BU/Region, specifically related to pre-market risk management file (RMF) support and alignment with QMSR regulation or Regional regulations
• Establish and conduct monthly BU RMF Safety Forums with the BU MSS
• Establish and conduct, at a minimum, quarterly Regional Safety Forums with the Regional RSS
• Providing medical support for Risk Strategy, Risk Assessment, and Risk Minimization for BD products in partnership with other BD functions including Quality and Regulatory Affairs
• Support medical safety data inquiries/Health Authority Responses
• Serve as a trusted partner to other functions in representing the view on product safety and lead in a matrix environment through scientific competency and organizational influence and impact
• Contribute to departmental and cross-functional improvement initiatives
• Providing clinical/medical expertise in supporting activities such as participating on cross-functional teams such as SOP committees, taskforces, work streams and representing GMS&G positions, processes and guidance's to cross-functional business partners

Requirements

• Understanding of the medical device development process
• Understands Good Clinical Practice and Safety Monitoring processes and regulations
• Understands and encourages a consistent approach to the Severity of Harm determinations used throughout the risk management process
• Ability to leverage the range of available tools to investigate safety concerns
• Understanding of regulatory requirements for safety assessment and action
• Qualified in GCP, GLP clinical activities and able to adjudicate Adverse Events (AE,SAE,UADE) as it relates to seriousness, relatedness to the device, or procedure.
• Strong scientific analytical reasoning skills
• Ability to work on multiple complex projects in parallel
• Excellent attention to detail
• Behavioral competencies necessary to work and lead a team within a complex matrix environment
• Excellent verbal and written communication skills
• Medical degree (MD, D.O.) preferred, PharmD, P.A., APRN, or RN depending on Industry experience.
• At least 5 years of medical device industry and/or pharmaceutical experience, including experience in pre-market activities
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Why Join Us?
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers .
• Required Skills
• Optional Skills
• .
• Primary Work Location
• USA NJ - Franklin Lakes
• Additional Locations
• Work Shift
• Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
• Our pay is based on the role and the necessary skills a

Benefits

Additional Information

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description

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