Medical Director, Medical Safety Officer - Franklin Lakes, United States - BD

Verified Company

Franklin Lakes, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Description Summary:

We are the makers of possible**:
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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a
maker of possible with us.

BD's Corporate Development Department has responsibility for supporting the development and execution of both short
- and long-term growth strategies of the Company and partnering with its worldwide business units, regions, and innovation center. Individuals in the Department identify, evaluate, value, structure and negotiate business opportunities including acquisitions, divestitures, strategic alliances, and equity investments. The Department develops and acts as an objective advisor regarding the strategic fit, valuation, and structuring of these numerous opportunities. Individuals in the Department are expected to provide overall project / deal management and, where appropriate, to work with the Leadership Teams of worldwide business units. Finally, the Department is responsible for shaping and executing BD's corporate strategy as well as developing and maintaining valuation models and transactional, diligence and integration processes.

The Medical Director, Medical Safety Officer (Clinical) plays a pivotal role in establishing and maintaining a medical/clinical safety oversight and collaborative relationship with the BD Business Unit (BU) Medical Affairs.

This role is a function of the centralized BD Global Medical Safety and Governance (GMS&G) organization and reports directly to the V.P., GMS&G.

Responsibilities:

Comanage and support Clinical Safety Specialist (CSS) for their respective BU
Responsibility in the area of Signal Detection/Safety Surveillance, evaluate and integrate data from multiple sources, including clinical, nonclinical and realworld to understand and manage safety signals and the communication of these issues to the VP, Global Medical Safety and Governance
Oversight for central MA BD Pharmacovigilance
Participation in oversight activities (e.g., Clinical Safety and Drug Safety Review Board core member) and providing clinical/medical expertise on individual event reports and signal detection methods
Establish and maintain Clinical Safety training programs
Establish and conduct monthly Clinical Safety Forums with the BU CSS
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 clinical safety data inquiries/Health Authority Responses
Serve as a trusted partner to other R&D 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 crossfunctional improvement initiatives
Providing clinical/medical expertise in supporting activities such as participating on crossfunctional teams such as SOP committees, taskforces, work streams and representing GMS&G positions, processes and guidance's to crossfunctional 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
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 clinical trial experience
At least 5 years of medical device industry and/or pharmaceutical experience, including experience in pre and postmarket activities
High level of medical competence, with an ability to balance this with industry standards to achieve business goals

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.

In some locations, testing for COVID-19 may be available and/or required. Consistent with B