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BD (Becton, Dickinson and Company) Clinical Safety Specialist II (remote USA) in Tempe, Arizona

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Clinical Safety Specialist (CSS) II will provide safety support for assigned clinical trial(s) and/or survey(s) as needed. Along with Global Clinical Affairs (GCA), supports and oversees clinical safety activities. Ensure that any required safety reporting to regulatory authorities bodies is performed. As directed by the CSS Manager or CSS Supervisor the CSS II is responsible for assuring safety standards and regulatory compliance are consistent with corporate and division policies, government regulations, international standards and standards of the medical device industry. Actively participates in safety guidance, verification and execution of activities pertaining to clinical trials and product surveys.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

  • Process, review, evaluate, and track incoming AEs for assigned studies.

  • Escalates events as appropriate per study specific safety plan to designated recipients.

  • Works collaboratively with Regulatory Affairs (RA), Clinical Affairs (CA), and Medical Monitor (MM) on events requiring expedited review or regulatory reporting.

  • Provide safety input for Clinical Investigation Plans, Investigator’s Brochures, and clinical study reports, as needed.

  • Support additional safety related tasks (e.g. MM safety reviews, CEC adjudication activities, DSMB reports for trending review) as directed.

  • Coordinate with Complaints/Vigilance Reporting to ensure Medical Device Reporting (MDR) requirements are met.

  • Support the development and maintenance of safety reporting metrics for assigned studies.

  • Provide support in the start up process for new committees, such as the CEC/DMC/DSMB, as appropriate for assigned studies.

  • Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.

  • Assist in the development and maintenance of clinical safety tracking tools and work instructions.

  • Provide clinical study support for internal and external audits and inspections.

  • Assist Post-Market (PM) surveillance team and internal complaints staff as necessary.

  • Keeps abreast of regulations and requirements to maintain regulatory compliance.

  • Participates as required, in training on regulatory issues, products, disease states, safety, etc.

  • Bring regulatory compliance questions/issues to the attention of CSS Manager.

  • Ensures all changes to safety events in EDC occur in a timely manner and performs the necessary follow-up to prevent any conflicts or delays to business goals.

  • Maintain current status related to training modules.

  • Assist in the development and evaluation of new processes and procedures and suggest continual improvements.

  • Participate and represent safety on projects, implementations and initiatives associated with regulatory compliance, integration and optimization as assigned.

Required Qualifications:

  • Must have the flexibility to handle several work streams simultaneously, multitask, and set priorities effectively to complete daily work, meet deadlines and handle urgent demand.

  • A minimum of 3 years of clinical research experience, ideally with 1-2 years of 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 812, ISO, GCP, and other relevant human studies principals

  • Proficient knowledge of FDA regulations regarding device research and development is required

  • Excellent communication skills (oral and written)

  • Strong attention to detail

  • Strong interpersonal and organizational skills

  • Ability to work independently, manage multiple tasks and personnel in a fast paced environment

  • Ability to travel up to 10%

  • Ability to work effectively on cross-functional teams.

Preferred Qualifications:

  • Previous experience with medical device clinical studies

  • Experience with electronic Trial Master File (eTMF)

  • Experience with Electronic Data Capture (EDC) and Clinical Trial Management Software (CTMS)

Education and/or Experience:

  • RN/BA/BS or equivalent combination of training experience

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

For many 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, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/ #joinbd #LI-PRO

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.

PDN

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

USA CA - San Diego Bldg A&B, USA CA - San Jose, USA MD - Sparks - 7 Loveton Circle, USA NC - Research Triangle Park, USA NJ - Franklin Lakes, USA TX - San Antonio, USA UT - Sandy, USA WA - Seattle

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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