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Job Overview
Akebia is a leading pharmaceutical company dedicated to improving the lives of individuals affected by kidney disease. As a Medical Director, you will play a vital role in shaping the company's safety strategy and ensuring the development of innovative therapeutics.
The successful candidate will have extensive experience in drug safety and pharmacovigilance, with a strong understanding of US and EU regulations. They will be responsible for analyzing clinical and post-marketing safety data, leading medical reviews of ICSRs, and contributing to aggregate safety reports.
Key Responsibilities:
- Analyze and interpret clinical and post-marketing safety data
- Lead medical reviews of ICSRs and other drug safety information
- Contribute to aggregate safety reports, including development safety update reports and periodic benefit-risk evaluation reports
Requirements:
- 6 years' experience in drug safety and pharmacovigilance
- Medical Doctor (MD) or internationally recognized equivalent MD