Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is seeking a Submissions Manager, GPS Operations to manage Global Patient Safety operational activities for assigned clinical programs. The role oversees safety report submissions, regulatory compliance, submission tracking, cross-functional coordination, vendor oversight, and process improvement.
Responsibilities
- Manage and oversee timely and compliant submission of ICSRs, expedited safety reports, and aggregate reports to global health authorities and other required recipients
- Ensure PV submissions meet applicable FDA, EMA, ICH, and country-specific regulatory requirements and timelines
- Monitor submission compliance, acknowledgments, rejections, and exceptions; investigate issues and drive timely resolution and CAPAs as needed
- Maintain submission documentation, metrics, and compliance tracking to support audit and inspection readiness
- Partner with Global Patient Safety, Regulatory Affairs, Clinical Operations, Quality, and other cross-functional teams to coordinate safety reporting requirements and deliverables
- Oversee PV submission activities performed by CROs, vendors, and partners, including performance monitoring and issue escalation
- Develop and maintain PV submission procedures and identify opportunities to improve quality, efficiency, compliance, and scalability
Skills
- • Bachelor's Degree in a healthcare field
- • Minimum of 5 years of relevant experience in pharmacovigilance operational activities
- • Hands-on experience working with CROs/vendors/partners
- • Strong background in safety reporting, regulatory compliance, and global safety reporting/regulations in clinical trials
- • Able to problem solve, focus on details, multitask, prioritize options, work independently, anticipate challenges, and execute assigned deliverables
- • Ability to analyze situations and data that require conceptual thinking and in-depth knowledge of organizational objectives
- • Ability to persuade others in sensitive/complex situations while maintaining relationships
- • An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment
- • Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors
- • Exercise discretion regarding highly confidential internal and external communications
- Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate
- • Master's Degree or higher in a healthcare field
- • 7+ years of relevant experience in pharmacovigilance operational and submission activities
Benefits
- Remote role
- W2 contract
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