Safety Regulatory Director
1 week ago
We are seeking a seasoned leader to oversee global safety intake and regulatory submissions.
Tertiary Responsibilities:- Oversight of processes and systems enabling initial adverse event data capture via electronic database entry, phone lines, etc.
- Regulatory compliance and reporting of Individual Case Safety Reports (ICSRs) to health authorities, partners, and internal destinations.
- Follow-up activities for accuracy and completeness of safety information.
- Lead a team for all aspects of intake and ICSR submissions for the company product portfolio.
- Maintenance and oversight of reporting rules in the global safety database, Argus.
- Metrics creation to measure intake and reporting compliance.
- Serve as ICSR Intake and Submission subject matter expert for audits and inspections.
- Train and mentor staff on safety information.
- Input into contract deliverables for outsourced activities.
This role requires knowledge of clinical research process and pharmacovigilance regulations. The ideal candidate will have previous people management experience, excellent written and verbal communication skills, and problem-solving abilities for moderate to complex issues and trends.
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