Senior Manager, Global Patient Safety Specialist
1 week ago
Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.
We are seeking an experienced Senior Manager to join our team. This role will be responsible for Intake and ICSR submissions for the company product portfolio, covering pre and post-marketing activities.
Key Responsibilities- Contribute to Intake responsibilities for Argus events, as well as all aspects of ICSR submission start-up process.
- Track and monitor ICSR timelines to ensure timely submissions to regulatory agencies, Collaborators, internal destinations, and contract research organizations (CROs).
- Proactively investigate potential issues or noncompliance and raise trends and critical issues to Management.
- Lead investigations of non-compliance issues and identify root cause for late ICSR submissions.
- Address and implement corrective actions related to ICSR submission activities.
- Bachelor's degree, Master's preferred, in a life science or clinical research field.
- A minimum of 8 years of experience in drug safety and safety reporting in pharmaceutical/biotech industry.
- Strong knowledge and understanding of clinical research processes and global pharmacovigilance regulations, systems, and processes.
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.
Regeneron is an equal opportunity employer and welcomes applications from diverse candidates.
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