
Chief Medical Safety Expert
2 weeks ago
The role of a Senior Medical Safety Advisor involves providing medical expertise in evaluating safety data from various sources as part of the overall pharmacovigilance process. This entails determining the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile.
As a senior technical leader, this position participates in matrix management activities, including preparation or participation in evaluating safety issues and preparing aggregate reports in collaboration with post-marketing safety experts and safety surveillance groups.
Key Responsibilities:
- Conduct medical reviews and clarifications 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 reviews 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
Required Qualifications:
- MBBS OR MD from an accredited and internationally recognized medical school
- Three plus years of experience practicing clinical medicine after award of medical degree
- Two plus years of pharmacovigilance experience required
- Sound knowledge of Medicine
- In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements
Benefits of Working with Our Team
Our team offers a dynamic work environment where professionals can grow their careers while contributing to the advancement of public health.
How to Apply
To apply for this role, please submit your application through our website.
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