Medical Director, Medical Safety Officer

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.

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
• Responsibility in the area of Regional Signal Detection/Safety Surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world to understand and manage safety signals and communication to the VPs, of Regional Medical Affairs and Global Medical Safety and Governance
• 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 guidances to cross-functional business partners

Qualifications:

• 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

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, youll discover a culture in which you can learn, grow and thrive.

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 .

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You ."

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 and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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