Job Title: Medical Physician Specialist I
Locations: Available in 2 locations
Category: Clinical
Job ID: 254882
Provide medical safety expertise to sponsors of drugs, devices, and combination products during the post-marketing period. Support clinical safety case review, aggregate analysis, and team guidance to ensure high-quality, compliant, and timely medical safety services.
Case Review & Medical Assessment
Perform primary medical review of cases, including:
Assessing case seriousness.
Determining listedness/labeling compliance.
Evaluating causality.
Coding adverse events accurately.
Reviewing and drafting patient narratives.
Update and document daily case data and case feedback in tracking tools to support workflow management.
Conduct aggregate and signal analysis activities in support of single case processing.
Team Support & Training
Provide training and guidance on medical aspects of case processing to the case processing team (after one year of tenure).
Promote a culture of high customer service and professional excellence.
Compliance & Deliverables
Ensure all assigned deliverables meet expected quality, compliance, and productivity standards.
Maintain knowledge of regulatory requirements for clinical research and safety reporting.
Follow ICH-GCP guidelines in all safety activities.
Education
Bachelor’s degree in Medical Science, MD, DO, or equivalent.
Relevant or equivalent experience may be considered in lieu of formal education.
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, therapeutics, drug treatments, and procedures.
Understanding of regulatory requirements for clinical research and pharmacovigilance.
Familiarity with ICH-GCP guidelines.
Preferred
1–2 years of clinical practice experience.
Office-based or home-based, as directed by line manager.
Assume accountability for all assigned deliverables.
Support high-quality medical safety operations.
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