Job Title: Associate Medical Manager
Locations: Available in 2 locations
Category: Clinical
Job ID: 253718
Provide medical safety expertise to sponsors of drugs, devices, and combination products during the post-marketing period. This role involves direct medical case review, quality assurance, and signal detection activities, while supporting compliance with regulatory and client standards.
Medical Case Review & Oversight
Undertake primary medical review of cases, including assessment of seriousness, labeling, causality, adverse event coding, and narrative review.
Update and document daily case data and feedback using appropriate trackers/tools to facilitate workflow and case management.
Perform secondary medical review (Quality Control) and retrospective review (Quality Assurance) as required.
Conduct aggregate medical review and signal detection/analysis activities.
Training & Mentorship
Provide training and guidance to the case processing team on medical aspects of case processing.
Identify error trends, training needs, and areas for improvement based on QA/QC activities.
Client & Process Management
Maintain and enhance client relationships wherever possible.
Participate in process improvement initiatives across the organization.
Ensure accountability for deliverables, adhering to quality, compliance, productivity, and KPI standards.
Other Duties
Perform additional duties as assigned to support medical and safety functions.
Bachelor’s degree in medical science, MD, DO, or equivalent. (Relevant experience may substitute.)
Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and procedures.
Understanding of regulatory requirements for clinical research.
Knowledge of ICH-GCP guidelines.
Fluent in English (Speaking: ILR level 3+, Reading/Writing: ILR level 4+).
Up to 2 years of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or clinical research.
1–2 years of clinical practice experience.
Understanding of regulatory requirements related to pharmacovigilance.
Office or home-based environment as requested by the line manager.
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