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Medical Reviewer/Safety Reviewer III
Mindlance
- 🇺🇸 United States
- On-site
- Manager or above
- 23 hours ago
- Risk Management
- Windows
- Excel
- Oracle
23 hours ago
Must have current RN licensing
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
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
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). Troubleshoots problems. 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
Other duties may be assigned based on the need or work requirement of the department deliverables
Responsibilities
medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and Client community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
Experience Level = 5-7 Years
Qualifications:
Bachelor’s degree with related health sciences background BSN, BS, or Engineering
Candidates lacking the appropriate degree but with previous medical device experience may be considered
4-7 years medical device safety experience minimum
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.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Medical Reviewer/Safety Reviewer III · Mindlance