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 ReportsPreferred candidate profile- MBBS or MD doctor in Pharmacology
Job Title
Pharmacovigilance Manager