Senior Submissions Officer
Job Summary
Supporting the client in all aspects of safety submission, the full-time Senior Submissions Officer will assist in the development and maintenance of submission processes, ensure compliance with global regulatory reporting requirements, and perform quality control of safety submission activities while working remotely.
Key responsibilities
- Manage submissions of Individual Case Safety Reports (ICSRs) and aggregate reports to relevant parties
- Support the Submission Manager in developing and documenting submission processes and standards
- Provide training for junior team members and act as a Subject Matter Expert (SME) during audits and inspections
Required qualifications
- Life science graduate, pharmacy, nursing, or other healthcare-related qualification
- 3-5 years of work experience in pharmacovigilance, with at least 2 years focusing on submissions
- Strong organizational skills, including attention to detail and multitasking abilities
- Management skills, including time and issue management
- Fluency in English, both spoken and written
Complete Job Description
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