Medical Reviewer
Aptita
Job Description
MR (SME/TL)- Safety Physician/Medical Reviewer/post lock Medical Review – Quality Review Associate*
Support medical function for the assigned activities
Graduate/Postgraduate/Doctorate degree in Medical sciences or equivalent degree (MBBS/MD).
Minimum 2 years of experience in medical review of ICSRs in safety databases like Veeva Safety and Argus.
Fluency in English
MR (TM): Team Manager – Medical Review
Manage and oversee the Medical Review team (Safety Physicians/Medical Reviewers) handling medical review of ICSRs and post-lock medical QC.
Own quality and turnaround metrics for medical review deliverables; drive root-cause analysis and CAPA for medical review defects.
Conduct resource planning, workload allocation, and capacity forecasting for the medical review team based on case volumes.
Provide clinical/medical guidance and calibration to Medical Reviewers on complex causality assessment, labeling, and listedness decisions.
Represent the medical review function in client governance calls; present quality trends and process improvements.
Conduct performance appraisals, mentoring, and career development for Medical Reviewers; ensure compliance with SOPs and regulatory timelines.
Graduate/Postgraduate/Doctorate degree in Medical sciences or equivalent degree (MBBS/MD)
Minimum 5-7 years of experience in medical review of ICSRs in safety databases like Veeva Safety and Argus, including at least 2 years in a team management/supervisory role.
Fluency in English