Pharmacovigilance Submissions Manager

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

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 role can be done remotely and will be offered as a 12-month renewable contract.

• 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.

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.