Global PV Submissions Manager - Remote 12-Month Contract

Redbock - an NES Fircroft company; California; Remote; USD 110,000 - 160,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Submissions Manager to oversee global patient safety submissions, including ICSRs and safety reporting, with a remote-ready, 12-month renewable contract. The role emphasizes regulatory compliance, cross-functional collaboration, and vendor oversight across global health authorities.

The ideal candidate brings 5+ years in pharmacovigilance operations, CRO/vendor management experience, and strong analytical skills to drive timely, compliant

Qualifications

• Bachelor's degree in a healthcare field is required.
• Minimum 5 years of relevant pharmacovigilance experience.
• Hands-on experience with CROs/vendors/partners.
• Strong safety reporting regulatory knowledge (FDA/EMA/ICH/global).
• Ability to work independently, multi-task, and meet deadlines.
• Strong analytical thinking and problem-solving skills.
• Excellent interpersonal and cross-functional collaboration abilities.
• Discretion with highly confidential information.

Responsibilities

• Manage timely and compliant submission of ICSRs and safety reports to authorities.
• Ensure submissions meet regulatory requirements and timelines.
• Monitor submissions, acknowledgments, rejections, and CAPA where needed.
• Maintain submission documentation, metrics, and audit-ready records.
• Coordinate safety reporting with Global Patient Safety, Regulatory Affairs, Clinical Ops, Quality, and partners.
• Oversee PV submission activities by CROs and vendors, monitor performance.
• Develop and improve PV submission procedures for quality and efficiency.

Skills

Pharmacovigilance

Regulatory compliance

Vendor management

Cross-functional collaboration

Attention to detail

Problem solving

Data analysis

Communication

Education

Bachelor's degree in a healthcare field

Master's degree or higher in a healthcare field

Job description

Redbock - an NES Fircroft company is seeking a Submissions Manager to oversee global patient safety submissions, including ICSRs and safety reporting, with a remote-ready, 12-month renewable contract. The role emphasizes regulatory compliance, cross-functional collaboration, and vendor oversight across global health authorities.

The ideal candidate brings 5+ years in pharmacovigilance operations, CRO/vendor management experience, and strong analytical skills to drive timely, compliant