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5 days ago
Overview:
The role of the Senior Medical Safety Advisor is to provide medical expertise in the evaluation of safety data from various sources, as part of the overall pharmacovigilance process. This involves determining the medical and scientific relevance of serious adverse event reports within the context of a product's safety profile.
Key Responsibilities:
- Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
- Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases
- Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
Requirements:
- MBBS or MD from an accredited and internationally recognized medical school
- Three plus years experience practicing clinical medicine after award of medical degree
- Two plus years of pharmacovigilance experience
- Sound knowledge of Medicine
- In-depth knowledge of global, regional and local clinical research regulatory requirements
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