Job Description
Job description - Medical Reviewer
Responsible for Medical review of Company and Literature and Regulatory cases
Appropriate selection of adverse events and assessment of seriousness criteria
MedDRA Coding of the adverse events
Review of reporter/company causality and Label assessment
Selection of product role (suspect, concomitant or interacting) and concomitant conditions, medical history, and laboratory data
Case Narrative evaluation
Drafting/Quality/Medical review of aggregate reports (Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs)
Medical review of Risk Management Plans (RMPs)
Medical review of Signal Management Reports
Preferred candidate profile
MBBS or MD doctor in Pharmacology
Responsible for Medical review of Company and Literature and Regulatory cases
Appropriate selection of adverse events and assessment of seriousness criteria
MedDRA Coding of the adverse events
Review of reporter/company causality and Label assessment
Selection of product role (suspect, concomitant or interacting) and concomitant conditions, medical history, and laboratory data
Case Narrative evaluation
Drafting/Quality/Medical review of aggregate reports (Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs)
Medical review of Risk Management Plans (RMPs)
Medical review of Signal Management Reports
Preferred candidate profile
MBBS or MD doctor in Pharmacology