Pharmacovigilance Submission Manager

Redbock - an NES Fircroft company; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Redbock - an NES Fircroft company seeks a Submissions Manager – Global Patient Safety for a 12-month renewable contract, fully remote in the United States. You will manage safety data collection and reporting across clinical programs.

Responsibilities include timely, compliant submissions to global health authorities, cross-functional collaboration, and overseeing CRO/vendor activities to ensure regulatory readiness and continuous improvement.

Qualifications

• Bachelor’s degree in a healthcare field.
• Minimum of 5 years in pharmacovigilance operational activities.
• Hands-on experience working with CROs/vendors/partners.
• Strong background in safety reporting regulatory compliance.
• Ability to analyze data and think strategically.
• Excellent interpersonal skills and cross-functional collaboration.
• Discretion with confidential communications.

Responsibilities

• Manage and oversee timely and compliant submission of regulatory reports to health authorities.
• Ensure PV submissions meet FDA/EMA/ICH/regional requirements and timelines.
• Monitor submission compliance, rejections, CAPAs, and drive timely resolution.
• Maintain submission documentation, metrics, and audit readiness.
• Coordinate safety reporting with cross-functional teams and CROs/vendors.
• Oversee PV submission activities by CROs, vendors, and partners; monitor performance.
• Develop and maintain PV submission procedures and identify efficiency improvements.

Skills

CRO/vendor management

Regulatory compliance knowledge

Global safety reporting knowledge

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in healthcare

Master's degree or higher in healthcare

Job description

12 month renewable contract - fully remote

Submissions Manager – Global Patient Safety

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. This can be done remotely and will be for a 12 month renewable contract.

• Manage and oversee timely and compliant submission of IC*RS, 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.

Required Skills, Experience and Education:

• 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, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables.
• Ability to analyze situations and data that requires 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 capacity to be effective in a dynamic, continuously improving, and fast-paced company environment.
• Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors.
• Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

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