Medical Reviewer

Stark Pharma Solutions Inc; Piscataway Township (NJ); Teletrabalho; USD 90 000 - 140 000; Tempo integral

Resumo da oferta

Stark Pharma Solutions Inc. is seeking a Medical Reviewer to assess medical device safety cases, adverse events, and deficiencies. The role requires active RN licensure, a related degree, and several years of device-safety experience.

You will review data, ensure regulatory compliance, and collaborate with safety teams to support timely case processing. The candidate will mentor staff, lead safety projects, and coordinate cross-functional activities while maintaining high-quality documentation

Qualificações

• Current Registered Nurse (RN) license is required.
• Bachelor's degree in Nursing (BSN), Health Sciences, Engineering, or related field preferred.
• 4–7 years of medical device safety experience.
• Experience reviewing medical device adverse events, complaints, and device deficiencies.
• Knowledge of medical device safety regulations and risk management requirements.
• Ability to escalate findings appropriately.
• Experience with project coordination, process management, and cross-functional collaboration.
• Proficiency in Microsoft Word, Excel, and EDMS.
• Experience with Oracle Clinical or OneTrack is beneficial.

Responsabilidades

• Collect, review, and process medical device adverse event reports and device deficiencies.
• Perform seriousness, labeling, causality, and follow-up data assessments.
• Conduct medical assessments for post-market medical device safety cases and escalate when necessary.
• Ensure compliance with global medical device safety regulations, standards, and guidelines.
• Support audits, inspections, safety surveillance, and database reconciliation.
• Prioritize workloads, troubleshoot issues, and escalate problems appropriately.
• Mentor and train Medical Device Safety team members.
• Lead safety projects and coordinate cross-functional activities.
• Review and communicate medical data through written reports and presentations.
• Assign and coordinate tasks to support Physicians.

Conhecimentos

RN License

Medical safety

Regulatory knowledge

EDMS

Oracle Clinical

OneTrack

Written communication

Mentoring

Formação académica

BSN

Health Sciences

Engineering

Related field

Ferramentas

EDMS

Oracle Clinical

OneTrack

Descrição da oferta de emprego

About the Company
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Medical Reviewer
Location: Remote
Duration: Long Term

Job Overview
We are seeking a Medical Reviewer / Safety Reviewer III to review and assess medical device safety cases, adverse events, and device deficiencies. The role involves medical data evaluation, regulatory compliance, safety reporting, and collaboration with medical safety teams to ensure accurate and timely case processing.

Key Responsibilities

• Collect, review, assess, and process medical device adverse event reports and device deficiency information from clinical studies.
• Perform seriousness, labeling, causality, and follow-up data assessments.
• Conduct medical assessments for post-market medical device safety cases and **escalate** cases to Medical Device Safety Physicians when necessary.
• Ensure compliance with global medical device safety regulations, standards, and guidelines.
• Support audits, inspections, safety surveillance, and database reconciliation activities.
• Prioritize workloads, troubleshoot issues, and **escalate** problems appropriately.
• Mentor and train Medical Device Safety team members.
• Lead assigned safety projects and coordinate cross-functional activities.
• Review and communicate medical data accurately through written reports and presentations.
• Assign and coordinate tasks when required to support Medical Device Safety Physicians.

Required Qualifications

• Current Registered Nurse (RN) license required.
• Bachelor's degree in Nursing (BSN), Health Sciences, Engineering, or a related field preferred; candidates with relevant medical device experience may also be considered.
• 4 7 years of medical device safety experience.
• Experience reviewing medical device adverse events, complaints, and device deficiencies.
• Knowledge of medical device and combination product safety regulations and risk management requirements.
• Ability to critically evaluate medical data and **escalate** findings appropriately.
• Experience with project coordination, process management, and cross-functional collaboration.
• Proficiency in Microsoft Word, Excel, Windows, and electronic document management systems (EDMS).
• Experience with systems such as Oracle Clinical or OneTrack is beneficial.
• Strong written communication, medical documentation, problem-solving, and mentoring skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.