Junior Assistant Medical Manager - Safety Nurse
Fortrea
Date: 3 weeks ago
City: Manila
Contract type: Full time
Job Overview
Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.
Summary Of Responsibilities
Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.
Summary Of Responsibilities
- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
- Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year.
- Performs aggregate and signal analysis activities, as required in support of single case processing.
- Creates, maintains, and assumes accountability for a culture of high customer service.
- Bachelor’s degree in Nursing.
- Preferrably with 2 years clinical experience
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills: Speaking: English at ILR level 3+ or higher.
- Writing / Reading: English at ILR level 4+ or higher.
- Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.
- Knowledge and understanding of regulatory requirements for Clinical Research.
- Knowledge and understanding of ICH-GCP guidelines.
- 2 years of Clinical practice experience or 2 years PV experience
- Office or home-based environment, as requested by the line manager.
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