Manager Medical Device Safety Analytics Remote
Manager Medical Device Safety Analytics Remote
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Job Description
Purpose:
Promotes patient safety through ability to independently review patient safetyrelated data from medical device/combination products in clinical trials or as part of postmarket 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 postmarket device portfolio cases escalating as need to the MDS physician
- Participate in investigation activities for departmental assigned childtask quality record investigation for device failures and human factorsrelated 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
Qualifications :
- Minimum: Bachelors 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 crosscollaborative relationships and facilitate meetings with proven success in resultsdriven 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 Physicians absence.
Additional Information :
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 shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
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 AbbVies 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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Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
