Senior Submissions Officer
About The Position
Supporting the client in all aspects of safety submission. Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards. Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance. Performing submissions of ICSRs/aggregate reports to all concerned parties. Performing exchanges of ICSRs with all concerned parties as per applicable documents. Providing support in all PV operations associated with Safety Reporting. Performing Quality control of ICSR Reportability Assessment. Performing Quality control of daily safety submission activities. Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area. Provide training for junior members of the team. Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards.
Requirements
- 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)
Responsibilities
- Supporting the client in all aspects of safety submission
- Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards
- Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance
- Performing submissions of ICSRs/aggregate reports to all concerned parties
- Performing exchanges of ICSRs with all concerned parties as per applicable documents
- Providing support in all PV operations associated with Safety Reporting
- Performing Quality control of ICSR Reportability Assessment
- Performing Quality control of daily safety submission activities
- Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
- Provide training for junior members of the team
- Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
