Submissions Manager, GPS Operations

Bayside Solutions; California; Remote; USD 130,000 - 180,000; Full time

Job summary

The ideal candidate has 5+ years in pharmacovigilance operations, hands-on CRO/vendor oversight, and a deep understanding of FDA/EMA/ICH requirements. This remote role requires detailed problem-solving and communication in a dynamic, fast-paced environment.

Qualifications

• Bachelor's Degree in a healthcare field required.
• Minimum 5 years in pharmacovigilance operational activities.
• Experience with CROs/vendors/partners.
• Strong knowledge of safety reporting and global safety regulations.
• Ability to analyze data and complex situations for decision making.
• Excellent collaboration across cross-functional teams.

Responsibilities

• Manage timely and compliant submission of ICSSRs, expedited safety reports, and aggregate reports to global health authorities.
• Ensure PV submissions meet FDA, EMA, ICH and country-specific requirements and timelines.
• Monitor submission compliance, rejections, CAPAs, and drive timely resolutions.
• Maintain submission documentation, metrics, and inspection readiness.
• Coordinate safety reporting with Regulatory Affairs, Clinical Operations, Quality, and CROs.
• Oversee PV submission activities performed by CROs/vendors and monitor performance.
• Develop and maintain PV submission procedures and identify opportunities to improve quality and efficiency.

Skills

Pharmacovigilance

Global Patient Safety

Regulatory Compliance

ICSR Submissions

Cross-functional Collaboration

Education

Bachelor's Degree in healthcare

Master's Degree in healthcare

Job description

Location:

Redwood City, CA - Remote Role

Job Summary:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.

Duties and Responsibilities:

• Manage and oversee timely and compliant submission of ICSSRs, 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.

Requirements and Qualifications:

• 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.

Preferred Qualifications:

• Master's Degree or higher in a healthcare field.
• 7+ years of relevant experience in pharmacovigilance operational and submission activities.

Desired Skills and Experience

Pharmacovigilance, Global Patient Safety, Safety Submissions, ICSR Submissions, Expedited Safety Reporting, Aggregate Safety Reports, Global Safety Reporting, Clinical Trial Safety, Regulatory Compliance, FDA Regulations, EMA Regulations, ICH Guidelines, Country-Specific Regulations, Submission Compliance, Safety Reporting Timelines, Submission Acknowledgments, Rejection & Exception Management, CAPA, Audit & Inspection Readiness, Compliance Metrics, PV Documentation, CRO & Vendor Oversight, Partner Management, Cross-Functional Collaboration, Regulatory Affairs, Clinical Operations, Quality Assurance, PV Procedures, Process Improvement, Data Analysis, Issue Resolution, Risk Management, Healthcare/Life Sciences

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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