To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $40 to $48 an hour. 

Client Industry: Pharmaceutical

Work Type: 100% Remote

Duration: 12 Months Contract, with potential extension based on performance and business

Job Summary:

We are seeking an experienced Medical Reviewer/Safety Reviewer  to support medical device safety management and regulatory compliance activities. The role involves reviewing and processing medical device adverse event reports, device deficiencies, and clinical study safety information. The selected candidate will perform medical assessments, evaluate case seriousness and causality, review follow up information, and escalate safety concerns to medical safety physicians. This position also supports safety surveillance, database reconciliation, audits, inspections, and mentoring of team members.

Key Responsibilities:

• Collect, review, assess, and process medical device adverse event reports and device deficiency information from clinical studies in compliance with global regulations and established timelines.
• Evaluate case seriousness, labeling, causality, and follow up information to ensure accurate and complete safety documentation.
• Perform medical assessments for post market medical device cases and escalate relevant findings to medical safety physicians as needed.
• Maintain current knowledge of medical device and combination product risk management regulations, applicable standards, and guidance documents.
• Support audits, inspections, safety surveillance, database reconciliation, and workload prioritization activities.
• Troubleshoot safety process issues, identify potential concerns, and escalate problems to management appropriately.
• Provide coaching and mentoring to designated medical device safety team members and support assigned safety activities.

Required Qualifications:

• Current and active Registered Nurse license.
• Bachelor degree in Nursing, Health Sciences, Engineering, or a related field. Candidates with relevant medical device experience but without the specified degree may be considered.
• Four to seven years of medical device safety experience.
• Experience reviewing medical data and evaluating adverse events, device deficiencies, and clinical study safety information.
• Knowledge of seriousness assessment, causality assessment, follow up data review, and global medical device safety regulations.
• Demonstrated ability to lead project activities, collaborate across teams, facilitate meetings, and manage results driven processes.
• Strong written and verbal communication skills, critical thinking, and problem solving abilities.
• Proficiency in Windows, MS Word, and MS Excel.

Preferred Qualifications:

• Experience with post market medical device surveillance and combination product safety management.
• Experience with electronic document management systems such as Oracle Clinical or OneTrack.
• Experience supporting regulatory audits and inspections.
• Experience mentoring team members and coordinating medical device safety activities.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)