Medical Reviewer (Mumbai)

Medical Reviewer (Mumbai)

13 Aug
|
Aptita
|
Mumbai

13 Aug

Aptita

Mumbai

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

📌 Medical Reviewer (Mumbai)
🏢 Aptita
📍 Mumbai

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