Education Qualification: MBBS/MD Candidate Specification: 2 years of relevant experience in ICSR or 1 year into aggregate reporting Location: Pan India Job Description:
As a Medical Reviewer you'll work on a variety of projects with responsibility for:
Online and offline Medical Review of safety reports in Argus Core and through line listing.
Review and validation/amendment of product coding.
Review/amendment of narrative for its appropriateness as per Novartis narrative writing conventions
Review and validation/amendment of event selection coding (as per MedDRA current version) grouping/ linking and event ordering.
Review and validation/amendment of seriousness criteria (as per applicable WP)
Support medical function for the assigned activities
Review and confirmation/amendment of Expectedness / Listedness / Labeling of the event
Determination and addition of causality (as per applicable WP)
Providing Medical Assessment Comment (MAC) where applicable (as per applicable WP).
Requesting for relevant follow-up information
Action item generation
Certain countries non serious cases have to be reviewed Responding to medical queries raised by the case processors and QC (Quality Control) associate and provide feedbacks to them
Reporting to Team leader/Team manager on performance status and any escalations
Provide triage support for medical judgement related queries.
Participating in product safety meetings
Responsible to conduct best practice sessions amongst team for quality improvement.
Employement Category:
Employement Type: Full time Industry: Pharmaceutical Functional Area: Pharmaceutical Role Category: Documentation Role/Responsibilies: Medical Reviewer
Contact Details:
Company: Golden Opportunities Location(s): Chennai