Senior Submissions Officer
RemoteUnited States
Job Summary
Support the Submission Manager in development, documentation, implementation, and maintenance of submission processes and standards. Ensure personal knowledge and understanding of global regulatory reporting requirements to ensure compliance while performing submissions of ICSRs and aggregate reports to all concerned parties. Execute exchanges of ICSRs with stakeholders as per applicable documents and perform quality control of ICSR reportability assessment and daily safety submission activities. Act as a subject matter expert for submissions in audits and inspections, representing business processes and standards. Provide training for junior team members and actively participate in trainings and maintenance of quality system documents for the Safety Reporting area. Requires a life science graduate with 3-5 years of pharmacovigilance experience, including 2 years on submissions, and fluency in English.
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 of experience working on submissions
- Organization skills, including attention to detail and multitasking
- Management skills, including time and issue management
- Communication skills, including clear and effective interaction with internal and external stakeholders
- English - fluent (spoken, written)
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