Medical Reviewer​/Safety Reviewer III

Reference: 631602

Posted:

Location:

North Chicago, Illinois Company:
Planet Pharma Group Contact:
Applications Email: applications

Pay range: 37-47/hr

* depending on experience

Job Description :

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
Experience/

Skills:

Minimum:  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, One Track)
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.

* CO/NYC candidates might not be considered