Job Description Summary

The Adverse Events & Risk Analyst I on the Clinical Team will be responsible for determining the reportability and conducting evaluations of adverse events. This role involves assessing the clinical use of products, analyzing data to minimize occurrence and risk, and identifying trends in adverse events and complaints. The Analyst will ensure that all product complaints are thoroughly documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO standards, FDA regulations, and Corporate, Division, and International policies and procedures.

Job Description

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. 

Responsibilities:

• Reportability Determination: Assess whether product malfunctions or serious injuries require reporting to the FDA, and determine if a 30-Day or 5-Day MDR report is necessary. Write and/or approve submitted MDRs.

• Collaboration: Work with external service providers (3rd party intake, BD Regional intake groups) to ensure timely documentation of complaint content.

• Decision Tree Review: Review and approve adverse event decision trees in Trackwise for US complaints.

• Complaint Review: Review and analyze complaints related to manufacturing, design, or clinical use issues. Ensure consistency and attention to detail in documentation for Medical Device Reports (MDRs).

• Data Analysis: Analyze complaints and adverse events and communicate findings and resolutions to management.

• Risk Assessment: Conduct clinical severity and risk assessments, classify, and assign FDA device and patient codes.

• Research: Identify US equivalents or similar devices for international products for MDR reporting.

• Subject Matter Expertise: Provide constructive feedback to improve processes or documentation of records. Drive updates to applicable area procedures as necessary.

• Litigation MDRs: Review and approve Litigation MDRs for legal complaints. Provide status updates to the UCC legal team as required.

• Other Duties: Perform other duties as assigned.

Education/Experience:

• Degree: Bachelor’s degree required.

• Experience: Preferred experience in FDA-regulated industries, complaint handling, MDR/adverse event reporting, and complaint investigations.

• Software Proficiency: Experience with Microsoft Office, complaint handling software (Trackwise or equivalent), Access Databases, and Excel (Pivot Tables and Charts).

• Regulatory Knowledge: Working knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 7, ISO 13485, and other international standards preferred.

Qualifications:

• Communication Skills: Excellent verbal, written, and presentation skills. Ability to present information appropriately based on the audience level.

• Time Management: Effectively manage time and prioritize tasks.

• Quality Requirements: Translate quality requirements into product specifications.

• Regulatory Interpretation: Interpret regulations, corporate, division, and department procedures.

• Quality Systems: Understand division and plant quality systems and implement systemic changes to enhance product quality and business efficiency.

• Industry Knowledge: Knowledge of medical device or similar regulated industries (pharmaceutical, aerospace) and international technical standards.

• External Communication: Communicate with external service providers via email and status reports to meet team targets and process expectations.

• Product Functionality: Thorough understanding of UCC device functionality to make informed quality decisions.

• Attention to Detail: Detail-oriented with a commitment to accuracy, efficiency, and consistency, including proofreading and documentation skills.

Language Skills:

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

• Ability to write routine reports and business correspondence.

• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees.

• Ability to communicate well with individuals at all levels of the organization.

Reasoning Ability:

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands:

• Regularly required to sit and talk or listen.

• Frequently required to use hands to finger, handle, or feel.

• Occasionally required to stand and reach with hands and arms.

• Lifts and/or moves up to ten pounds.

• May meet with other personnel in other areas of the building.

• Specific vision abilities required include close vision.

Work Environment:

• Normal office environment with a quiet to moderate noise level.

• Exposure to laboratory environments, which may require handling chemicals that present health, flammability, and reactivity hazards.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

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. 

Required Skills

Optional Skills

.

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift