Remote Global PV Submissions Manager

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

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.