Associate Medical Director for Clinical Safety
Há 4 dias
Associate Medical Director for Clinical Safety
We are looking for an Associate Medical Director to provide medical, scientific, and therapeutic expertise on pharmacovigilance services. This role involves participating in all aspects of the Medical Safety activities, including:
- Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summary.
- Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.
Key Responsibilities
- Serving as an internal consultant to pharmacovigilance case processing teams on projects.
- Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.
Requirements
- A medical degree from an accredited and internationally recognized medical school.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, including safety and good clinical practice.
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