MedDRA Coding Specialist

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