BD (Becton, Dickinson and Company) Clinical Safety Specialist in Tempe, Arizona
Job Description Summary
The Clinical Safety Specialist supports clinical study adverse event data collection, assessment, adjudication and analysis.
Process, review, evaluate, and track incoming adverse events for assigned studies,
Work collaboratively with Regulatory Affairs, Clinical Operations, and 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 regulatory compliance in adverse event definitions, adjudications and coding across studies as appropriate for the specified protocols,
Provide support in the start up process for new committees, such as the CEC / DMC / DSMB, as appropriate for assigned studies.
Lead preparation and coordination of 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 4 years of clinical research experience, ideally with 3 years clinical safety responsibilities;
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.).
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.
Primary Work LocationUSA AZ - Tempe BPV Building 1
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, or any other protected status.