What are the responsibilities and job description for the Medical Reviewer/Safety Reviewer position at Collabera?
The Medical Device Safety Team plays a critical role in ensuring patient safety by conducting medical reviews, assessing adverse events, and supporting regulatory compliance for medical devices and combination products. This high-impact team collaborates with Pharmacovigilance, Clinical, and Regulatory Affairs to analyze safety data, improve processes, and ensure compliance with global regulations (e.g., ICH, GCP, EU-MDR, FDA CFR).
Key Responsibilities:
- Conduct medical reviews of Case Report Forms (CRFs), including query resolution and addenda writing.
- Perform QA of data listings and assist in adverse event reporting for medical device incidents.
- Investigate and document Serious Adverse Events (SAEs) and device complaints, ensuring compliance with regulatory requirements.
- Collaborate with Medical Affairs, Clinical, and Regulatory teams to prepare safety documentation for health authorities.
- Support training initiatives on safety reporting and risk management for medical devices.
- Assist in continuous improvement projects, including automation and process optimization.
- Maintain knowledge of risk management regulations (e.g., ISO 14971, EU-MDR, FDA 21 CFR Part 803).
- Utilize electronic databases (e.g., Rave EDC, Veeva, Oracle, Salesforce) for case processing and reporting.
Required Skills & Experience:
✔ Active RN License (BSN Required) – Must be US-based.
✔ 3 years in clinical research, pharmacovigilance, or medical device safety.
✔ CRO or clinical trial experience (preferred).
✔ Proficiency in safety databases (e.g., Rave EDC, Veeva, Oracle) and Microsoft Office (Excel, Word, PowerPoint).
✔ Strong knowledge of regulatory guidelines (e.g., ICH-GCP, EU-MDR, FDA CFR).
✔ Ability to analyze data, prioritize tasks, and maintain high attention to detail.
✔ Excellent cross-functional communication & problem-solving skills.
Preferred Experience:
- Medical device/combination product safety reporting.
- Experience with IVD (In Vitro Diagnostic) cases.
- Familiarity with risk management standards (ISO 14971).
Salary : $40 - $45
