Job Title : Senior Medical Safety Advisor
Key Responsibilities Include :
- Medical Expertise : Provide medical knowledge in evaluating safety data and determining the relevance of adverse event reports within the context of a product's safety profile.
- Review and Clarify Adverse Events : Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
- Coding Review : Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
Main Responsibilities :
Consultant Role : Internal consultant to pharmacovigilance case processing teams on projects being supportedSafety Reviews : Medical safety review of protocol, Investigative Brochure, and / or Case Report Forms (CRFs)Aggregate Reviews : Aggregate reviews of safety information including clinical data, post marketing, literature review and observational studiesService Delivery : Service delivery from productivity, compliance and quality perspective within regulatory timelines