Pharmacovigilance Manager

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