Manager, Medical Device Safety Analytics (Remote)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose:

Promotes patient safety through ability to independently review patient safety-related data from medical device/combination products in clinical trials or as part of post-market surveillance. The primary responsibility is to assess the content, quality, and adherence of data to regulatory requirements and protocols by analyzing, triaging, and assessing Adverse Events and device deficiency information in addition to supporting clinical trial quarterly reporting, as this position impacts patient safety, product approval, and safety signal identification.

Responsibilities:

• Independently identify opportunities within the team for process efficiencies on an ongoing basis, supporting projects as required by business need
• Collect, review, assess and process complaints/reports with medical device adverse event and device deficiency information clinical studies in a compliant and timely manner to comply with global regulations, which includes but not limited to seriousness assessment, labeling, causality, follow- up data received
• Perform medical assessments as needed for post-market device portfolio cases escalating as need to the MDS physician
• Participate in investigation activities for departmental assigned child-task quality record investigation for device failures and human factors-related use errors
• Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with a high degree of competency
• Maintain understanding of medical device/combination product risk management regulations, as well as applicable standards, and guidance documents
• Supports and participates in audits and inspections as needed
• Develop cross functional relationships and effectively communicate with internal and external partners
• Workload responsibilities are primarily medical device safety management related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Problem solving involves identification of problems and proper escalation to manager
• Mentor/teach others with directions from leadership team by coaching and mentoring designated Medical Device Safety staff on assigned medical device safety activities. Support direct reports as required by the organizational needs.
• Other duties may be assigned based on the need or work requirement of the department deliverables

• Minimum:  Bachelor’s degree with related health sciences background BSN, BS, or Engineering or equivalent experience. Advanced degree preferred
• 5+ years medical device safety experience minimum
• Leadership experience required
• Demonstrated ability to lead project work, facilitate cross-collaborative relationships and facilitate meetings with proven success in results-driven process management PC proficiency (Windows, Word, Excel) and in EDMS (e.g., oracle/clinical, OneTrack)
• Critically evaluate medical data and escalate necessary information to Medical Device Safety Physicians as applicable
• Accurately and medically present data, both orally and in writing, with the ability to assign tasks to others in Medical Device Safety Physician’s absence.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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