Global PV Submissions Manager - Remote Contract

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

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.