BD (Becton, Dickinson and Company) Clinical Safety Specialist I in New Hope, Minnesota
Job ID: 2018-11537
Career Level: experienced
Location: New Hope,Minnesota,United States
Trailblazing Innovation for Patients
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients . Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
Summary of Position with General Responsibilities:
The Clinical Safety Specialist I coordinates and supports clinical study adverse event data collection, assessment, adjudication and analysis.
Essential job Functions:
Provide initial review, evaluation, and track incoming adverse events for assigned studies,
Escalate events as appropriate per study specific safety plan to designated recipients,
Assist in collaboration with Regulatory Affairs, Clinical Study Teams , and Medical Monitor on events requiring expedited review or reporting.
Work with Field Assurance to ensure timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations and company procedures,
Support additional safety-related tasks (e.g. Medical Monitor reports for aggregate trend review and signal detection) as directed,
Ensure consistency and compliance in applications of definitions for adjudication outcomes across assigned studies as appropriate for the specified protocols,
Provide support in preparing and coordinating CEC / DMC / DSMB meetings, or working with CROs who oversee this function, as applicable
Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
Bachelor’s degree or equivalent experience;
At least 2 years of clinical research experience, ideally with 1 year clinical safety responsibilities in medical device;
Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11, ICH-GCP, other relevant Guidance documents (ICH, FDA, EMA etc.).
Additional Desirable Qualifications Skills and Knowledge:
Experience in cardiovascular field
Familiarity with multiple EDC systems
Knowledge and working familiarity of MedRA coding and safety management systems (eg. AERS, ARGUS)
Working knowledge of medical terminology, acronyms, and ability to communicate effectively with medical personnel.
Strong Microsoft Office skills, including Excel, Word, and Power Point.
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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