09 Oct
|
Orcapod Consulting Services
|
Pune
09 Oct
Orcapod Consulting Services
Pune
Open level - SME, TL, TM - IC roles
Notice Period - Immediate to 30 days
Locations - Mumbai, Pune, Bangalore
MR (SME/TL)
Safety Physician/Medical Reviewer/post lock Medical Review Quality Review Associate*
Skills:
Support medical function for the assigned activities
Education:
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.
Skills:
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.
Education:
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
Valid PAN Number - _____________________(Why PAN Required > Mandatory to Process Candidature & Find Duplicity in Internal PAN Validation Process and also to initiate a screening call.
Please reach out in case of any queries.
Sonali Chattopadhyay I Associate People Success
Orcapod Consulting Services Pvt Ltd.
Email I
[email protected]
www.orcapodservices.com
(phone hidden)
📌 SME/TL/TM/Medical Reviewer (Pune)
🏢 Orcapod Consulting Services
📍 Pune